Trial Outcomes & Findings for Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC (NCT NCT05510908)
NCT ID: NCT05510908
Last Updated: 2026-08-14
Results Overview
For each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study: 1. Solid organ tumors associated with human papillomavirus (HPV) infection 2. Solid organ tumors unrelated to HPV 3. Kaposi sarcoma 4. Hematologic malignancies
Recruitment status
COMPLETED
Target enrollment
460 participants
Primary outcome timeframe
Enrollment
Results posted on
2026-08-14
Participant Flow
Participant milestones
| Measure |
New, Primary or Recurrent Disease
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Overall Study
STARTED
|
268
|
33
|
159
|
|
Overall Study
COMPLETED
|
268
|
33
|
159
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
Baseline characteristics by cohort
| Measure |
New, Primary or Recurrent Disease
n=268 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=33 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=159 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=11 Participants
|
59 years
n=11 Participants
|
59 years
n=22 Participants
|
57 years
n=255 Participants
|
|
Sex/Gender, Customized
Female
|
37 Participants
n=11 Participants
|
3 Participants
n=11 Participants
|
31 Participants
n=22 Participants
|
71 Participants
n=255 Participants
|
|
Sex/Gender, Customized
Male
|
221 Participants
n=11 Participants
|
30 Participants
n=11 Participants
|
125 Participants
n=22 Participants
|
376 Participants
n=255 Participants
|
|
Sex/Gender, Customized
Transgender
|
4 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=22 Participants
|
6 Participants
n=255 Participants
|
|
Sex/Gender, Customized
Not reported/Unknown
|
6 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=22 Participants
|
7 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
45 Participants
n=22 Participants
|
111 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
199 Participants
n=11 Participants
|
29 Participants
n=11 Participants
|
107 Participants
n=22 Participants
|
335 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
7 Participants
n=22 Participants
|
14 Participants
n=255 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=22 Participants
|
5 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
3 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Black or African American
|
101 Participants
n=11 Participants
|
17 Participants
n=11 Participants
|
61 Participants
n=22 Participants
|
179 Participants
n=255 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=11 Participants
|
15 Participants
n=11 Participants
|
70 Participants
n=22 Participants
|
210 Participants
n=255 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
26 Participants
n=22 Participants
|
59 Participants
n=255 Participants
|
|
Education
Never attended school
|
2 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=22 Participants
|
3 Participants
n=255 Participants
|
|
Education
High school graduate or below
|
57 Participants
n=11 Participants
|
7 Participants
n=11 Participants
|
48 Participants
n=22 Participants
|
112 Participants
n=255 Participants
|
|
Education
College degree or equivalent
|
77 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
47 Participants
n=22 Participants
|
135 Participants
n=255 Participants
|
|
Education
Unknown/not reported
|
132 Participants
n=11 Participants
|
15 Participants
n=11 Participants
|
63 Participants
n=22 Participants
|
210 Participants
n=255 Participants
|
|
Smoking history
Current use
|
54 Participants
n=11 Participants
|
10 Participants
n=11 Participants
|
31 Participants
n=22 Participants
|
95 Participants
n=255 Participants
|
|
Smoking history
Quit/former use
|
111 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
57 Participants
n=22 Participants
|
179 Participants
n=255 Participants
|
|
Smoking history
Never used
|
102 Participants
n=11 Participants
|
12 Participants
n=11 Participants
|
70 Participants
n=22 Participants
|
184 Participants
n=255 Participants
|
|
Smoking history
Unknown
|
1 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=22 Participants
|
2 Participants
n=255 Participants
|
PRIMARY outcome
Timeframe: EnrollmentFor each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study: 1. Solid organ tumors associated with human papillomavirus (HPV) infection 2. Solid organ tumors unrelated to HPV 3. Kaposi sarcoma 4. Hematologic malignancies
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=268 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=33 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=159 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Solid organ tumor associated with HPV infection
|
30 Participants
|
10 Participants
|
32 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Hematologic malignancies
|
43 Participants
|
0 Participants
|
35 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Kaposi sarcoma
|
87 Participants
|
6 Participants
|
15 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Solid organ tumors unrelated HPV
|
55 Participants
|
13 Participants
|
55 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Other
|
52 Participants
|
4 Participants
|
22 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: The participants who are eligible to meet site-based AMC trial eligibility
This will be calculated by the number of participants enrolled who meet site-based AMC trial eligibility compared to the number of eligible participants at each site who meet site-based AMC trial eligibility.
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=20 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=2 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=4 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Proportion of Participants Eligible for AMC Trials Who Are Successfully Enrolled
|
40 percentage of enrolled in AMC studies
|
50 percentage of enrolled in AMC studies
|
50 percentage of enrolled in AMC studies
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Participants who enrolled in this study
The distribution of participant cancer diagnosis variable will be summarized.
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=268 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=33 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=159 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Describe the Cancer Diagnostics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Kaposi Sarcoma
|
85 Participants
|
4 Participants
|
20 Participants
|
|
Describe the Cancer Diagnostics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Solid Tumors associated with HPV infection
|
30 Participants
|
7 Participants
|
36 Participants
|
|
Describe the Cancer Diagnostics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Solid Tumors unrelated to HPV
|
60 Participants
|
20 Participants
|
48 Participants
|
|
Describe the Cancer Diagnostics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Unknown
|
7 Participants
|
1 Participants
|
2 Participants
|
|
Describe the Cancer Diagnostics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Hematologic malignancy
|
86 Participants
|
1 Participants
|
53 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Participants who enrolled in this study
The distribution of participant gender variable will be summarized.
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=268 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=33 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=159 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Describe the Gender Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Male
|
221 Participants
|
30 Participants
|
125 Participants
|
|
Describe the Gender Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Transgender
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Describe the Gender Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Refused
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Describe the Gender Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Unknown
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Describe the Gender Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Female
|
37 Participants
|
3 Participants
|
31 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who enrolled in this study
The distribution of participant characteristics will be summarized. Continuous variables \[e.g. age, height, weight\] will be summarized as mean (std) if they are normally distributed, otherwise they will be summarized as median (IQR). Categorical variables \[e.g. tobacco use, ART medications, comorbidities\] will be summarized as frequency (%).
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=268 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=33 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=159 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Describe the Age Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Age: <50 years
|
104 Participants
|
9 Participants
|
35 Participants
|
|
Describe the Age Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Age:50-59 years
|
63 Participants
|
9 Participants
|
46 Participants
|
|
Describe the Age Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Age:60-69 years
|
77 Participants
|
13 Participants
|
64 Participants
|
|
Describe the Age Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Age: >=70 years
|
24 Participants
|
2 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Participants who enrolled in this study
The distribution of participant cancer treatment at enrollment will be summarized.
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=268 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=33 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=159 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Describe the Treatment Characteristics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Cancer Treatment at enrollment (Chemotherapy)
|
131 Participants
|
17 Participants
|
0 Participants
|
|
Describe the Treatment Characteristics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Cancer Treatment at enrollment (Non-chemotherapy)
|
33 Participants
|
5 Participants
|
0 Participants
|
|
Describe the Treatment Characteristics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Unknown
|
2 Participants
|
1 Participants
|
158 Participants
|
|
Describe the Treatment Characteristics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
No Cancer treatment at enrollment
|
102 Participants
|
10 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Participants who enrolled in this study
The frequency of planned cancer treatment regimens (at baseline) successfully initiated will be summarized.
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=268 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=33 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=159 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Planned Cancer Therapy for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment
Planned additional therapy
|
95 Participants
|
14 Participants
|
0 Participants
|
|
Planned Cancer Therapy for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment
No additional therapy
|
171 Participants
|
18 Participants
|
1 Participants
|
|
Planned Cancer Therapy for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment
Unknown/missing
|
2 Participants
|
1 Participants
|
158 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Participants who enrolled in this study with EORTC QLQ-C30 information
EORTC QLQ-C30 subscale and overall scores will be used to describe participant symptom and health-related quality of life burden. Baseline EORTC QLQ-C30 scores will be compared according to cancer group. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and single items assessing additional symptoms and perceived financial impact of the disease. Most questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=213 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=24 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=123 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Describe the Health-related QOL of Cancer Patients With HIV at Domestic AMC Sites Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Global Health
|
75 score on a scale between 0 and 100
Interval 7.14 to 92.86
|
60.7 score on a scale between 0 and 100
Interval 7.14 to 92.86
|
71.4 score on a scale between 0 and 100
Interval 7.14 to 92.85
|
|
Describe the Health-related QOL of Cancer Patients With HIV at Domestic AMC Sites Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Functional Scale
|
58.3 score on a scale between 0 and 100
Interval 5.0 to 76.67
|
58.3 score on a scale between 0 and 100
Interval 13.3 to 76.67
|
65 score on a scale between 0 and 100
Interval 21.67 to 76.67
|
|
Describe the Health-related QOL of Cancer Patients With HIV at Domestic AMC Sites Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Symptom Scale
|
44.2 score on a scale between 0 and 100
Interval 23.1 to 92.3
|
43.3 score on a scale between 0 and 100
Interval 26.9 to 90.38
|
34.6 score on a scale between 0 and 100
Interval 23.1 to 86.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Participants who enrolled with SCNS-SF34 baseline measurement
Supportive Care Needs Survey Short Form 34 \[SCNS-SF34\] scores will be used to categorize participants based on the degree to which their needs are met. Baseline SCNS-SF34 scores will be compared according to cancer group. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need); with a higher score indicating a higher level of need.
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=209 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=24 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=123 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Psychological needs
|
50.4 score on a scale between 0 and 100
Standard Deviation 21.5
|
54.9 score on a scale between 0 and 100
Standard Deviation 24.3
|
43 score on a scale between 0 and 100
Standard Deviation 18.7
|
|
Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Physical and daily living needs
|
51.6 score on a scale between 0 and 100
Standard Deviation 22.2
|
55.7 score on a scale between 0 and 100
Standard Deviation 25.7
|
45.3 score on a scale between 0 and 100
Standard Deviation 23.4
|
|
Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Sexual needs
|
40.8 score on a scale between 0 and 100
Standard Deviation 22.4
|
41.7 score on a scale between 0 and 100
Standard Deviation 17.7
|
35.5 score on a scale between 0 and 100
Standard Deviation 19.6
|
|
Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Care and support needs
|
39.7 score on a scale between 0 and 100
Standard Deviation 17.4
|
41.8 score on a scale between 0 and 100
Standard Deviation 17.1
|
36.6 score on a scale between 0 and 100
Standard Deviation 15.5
|
|
Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Health system and information needs
|
43.5 score on a scale between 0 and 100
Standard Deviation 18.6
|
44.9 score on a scale between 0 and 100
Standard Deviation 15.6
|
38.4 score on a scale between 0 and 100
Standard Deviation 15.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who enrolled with EORTC QLQ-C30 measurements for baseline and 12 weeks
EORTC QLQ-C30 will be summarized, both overall and at the \~12-week follow-up, according to participant characteristics and cancer groups. Overall change in QOL will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role,cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms and perceived financial impact of the disease. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=82 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=9 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=7 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Change of Quality of Life at 12 Weeks From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Global Health Scale
|
0 score on a scale between -100 and 100
Interval -57.1 to 85.7
|
0 score on a scale between -100 and 100
Interval -42.9 to 28.6
|
0 score on a scale between -100 and 100
Interval -14.3 to 14.3
|
|
Change of Quality of Life at 12 Weeks From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Functional Scale
|
1.7 score on a scale between -100 and 100
Interval -21.7 to 35.0
|
-2.5 score on a scale between -100 and 100
Interval -15.0 to 38.3
|
0 score on a scale between -100 and 100
Interval -1.7 to 3.3
|
|
Change of Quality of Life at 12 Weeks From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Symptom Scale
|
-1.9 score on a scale between -100 and 100
Interval -40.4 to 28.8
|
0 score on a scale between -100 and 100
Interval -26.9 to 13.5
|
0 score on a scale between -100 and 100
Interval 0.0 to 3.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who enrolled with SCNS-SF34 baseline and 12 week measurements
Supportive Care Needs Short Survey Form 34 \[SCNS-SF34\] scores will be summarized, both overall and at the \~12-week follow-up, according to participant characteristics and cancer groups. Overall change in scores will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need). Scores are averaged, and transformed to 0-100 scale;, with a higher score indicating a higher level of need.
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=77 Participants
Considering or currently receiving cancer treatment
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Metastic or Locally Advanced Cancer
n=9 Participants
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
|
Prior Cancer
n=7 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
|
|---|---|---|---|
|
Change of Needs From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]
Physical and daily living needs
|
-1.75 score on a scale between -100 and 100
Standard Deviation 19.1
|
9.5 score on a scale between -100 and 100
Standard Deviation 20.8
|
-0.8 score on a scale between -100 and 100
Standard Deviation 1.8
|
|
Change of Needs From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]
Psychological needs
|
-3.17 score on a scale between -100 and 100
Standard Deviation 16.5
|
0.3 score on a scale between -100 and 100
Standard Deviation 29.7
|
0.3 score on a scale between -100 and 100
Standard Deviation 1.4
|
|
Change of Needs From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]
Sexual needs
|
-3.2 score on a scale between -100 and 100
Standard Deviation 19.5
|
-4.2 score on a scale between -100 and 100
Standard Deviation 15.1
|
-1.1 score on a scale between -100 and 100
Standard Deviation 2.7
|
|
Change of Needs From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]
Care and support needs
|
-2.7 score on a scale between -100 and 100
Standard Deviation 14.0
|
9.3 score on a scale between -100 and 100
Standard Deviation 19.8
|
0 score on a scale between -100 and 100
Standard Deviation 0
|
|
Change of Needs From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]
Health system and information needs
|
-1.3 score on a scale between -100 and 100
Standard Deviation 17.4
|
1.8 score on a scale between -100 and 100
Standard Deviation 12.4
|
-0.3 score on a scale between -100 and 100
Standard Deviation 0.7
|
Adverse Events
New, Primary or Recurrent Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Metastic or Locally Advanced Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prior Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Deukwoo Kwon
Consortium for Advancing Management and Prevention of Cancer in People with HIV
Phone: 501 526-6724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place