Trial Outcomes & Findings for Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors (NCT NCT03316170)
NCT ID: NCT03316170
Last Updated: 2021-07-08
Results Overview
Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Day 0 baseline
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
Social Support + NRT Sampling
The treatment group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
3. a brief phone consult (10-15 minutes via phone) germane to smoking cessation,
4. a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and
5. a free, 2-week supply of nicotine patches and lozenges delivered via mail.
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
|
Social Support
The control group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Social Support + NRT Sampling
The treatment group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
3. a brief phone consult (10-15 minutes via phone) germane to smoking cessation,
4. a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and
5. a free, 2-week supply of nicotine patches and lozenges delivered via mail.
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
|
Social Support
The control group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
Baseline Characteristics
1 participant did not report their age
Baseline characteristics by cohort
| Measure |
Social Support + NRT Sampling
n=24 Participants
The treatment group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
3. a brief phone consult (10-15 minutes via phone) germane to smoking cessation,
4. a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and
5. a free, 2-week supply of nicotine patches and lozenges delivered via mail.
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
|
Social Support
n=25 Participants
The control group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.78 years
STANDARD_DEVIATION 9.27 • n=23 Participants • 1 participant did not report their age
|
56.00 years
STANDARD_DEVIATION 10.00 • n=25 Participants • 1 participant did not report their age
|
55.42 years
STANDARD_DEVIATION 9.58 • n=48 Participants • 1 participant did not report their age
|
|
Sex: Female, Male
Female
|
14 Participants
n=24 Participants
|
10 Participants
n=25 Participants
|
24 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=24 Participants
|
15 Participants
n=25 Participants
|
25 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=24 Participants
|
25 Participants
n=25 Participants
|
49 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=24 Participants
|
2 Participants
n=25 Participants
|
4 Participants
n=49 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=24 Participants
|
23 Participants
n=25 Participants
|
45 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=49 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants
|
25 Participants
n=25 Participants
|
49 Participants
n=49 Participants
|
|
Distress Thermometer (NCCN)
|
4.21 units on a scale
STANDARD_DEVIATION 2.95 • n=24 Participants
|
4.72 units on a scale
STANDARD_DEVIATION 3.45 • n=25 Participants
|
4.47 units on a scale
STANDARD_DEVIATION 3.19 • n=49 Participants
|
PRIMARY outcome
Timeframe: Day 0 baselinePopulation: Across all recruitment methods, a total of 551 individuals were contacted about the study; this number is not tied to study arm. Of these 551 individuals, a subset met the eligibility criteria, enrolled in the study, and were then randomized into one of the study arms.
Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100
Outcome measures
| Measure |
All Individuals Contacted
n=551 Participants
All individuals who were contacted about the study.
|
Social Support
The control group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
|
|---|---|---|
|
Accrual Percentage
|
8.9 percentage of participants enrolled
|
—
|
PRIMARY outcome
Timeframe: Through study completion, number of assessments at Day 60 follow-upPopulation: Participants enrolled in the study
Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100
Outcome measures
| Measure |
All Individuals Contacted
n=24 Participants
All individuals who were contacted about the study.
|
Social Support
n=25 Participants
The control group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
|
|---|---|---|
|
Retention
|
70.8 percentage of participant w/ assessments
|
72.0 percentage of participant w/ assessments
|
PRIMARY outcome
Timeframe: Day 60 follow-upPopulation: Analysis based on participants who completed the Day 60 assessment and provided data for this outcome
Total score on the Treatment Acceptability and Preferences measure (Sidani et al., 2009). This is a 4-item measure with each item scored on a scale from 0 to 4. Total scores are computed as the mean of the 4 individual items, so total scores range from 0 to 4. Higher scores indicate a better outcome, as they reflect greater acceptability of the treatment provided in this clinical trial.
Outcome measures
| Measure |
All Individuals Contacted
n=16 Participants
All individuals who were contacted about the study.
|
Social Support
n=17 Participants
The control group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
|
|---|---|---|
|
Acceptability
|
2.84 score on a scale
Standard Deviation 1.09
|
1.98 score on a scale
Standard Deviation 1.38
|
Adverse Events
Social Support + NRT Sampling
Serious events: 0 serious events
Other events: 8 other events
Deaths: 1 deaths
Social Support
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Social Support + NRT Sampling
n=24 participants at risk
The treatment group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
3. a brief phone consult (10-15 minutes via phone) germane to smoking cessation,
4. a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and
5. a free, 2-week supply of nicotine patches and lozenges delivered via mail.
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
|
Social Support
n=25 participants at risk
The control group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Breathing difficulty
|
25.0%
6/24 • Approximately 2 months
|
20.0%
5/25 • Approximately 2 months
|
|
General disorders
Burning in throat or mouth
|
12.5%
3/24 • Approximately 2 months
|
20.0%
5/25 • Approximately 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
3/24 • Approximately 2 months
|
16.0%
4/25 • Approximately 2 months
|
|
General disorders
Dizziness
|
20.8%
5/24 • Approximately 2 months
|
32.0%
8/25 • Approximately 2 months
|
|
General disorders
Dry mouth
|
25.0%
6/24 • Approximately 2 months
|
28.0%
7/25 • Approximately 2 months
|
|
General disorders
Excessive saliva
|
0.00%
0/24 • Approximately 2 months
|
12.0%
3/25 • Approximately 2 months
|
|
Nervous system disorders
Headache
|
16.7%
4/24 • Approximately 2 months
|
20.0%
5/25 • Approximately 2 months
|
|
Gastrointestinal disorders
Heartburn
|
16.7%
4/24 • Approximately 2 months
|
28.0%
7/25 • Approximately 2 months
|
|
Gastrointestinal disorders
Hiccups
|
0.00%
0/24 • Approximately 2 months
|
12.0%
3/25 • Approximately 2 months
|
|
General disorders
Insomnia
|
29.2%
7/24 • Approximately 2 months
|
32.0%
8/25 • Approximately 2 months
|
|
Cardiac disorders
Irregular heartbeat
|
8.3%
2/24 • Approximately 2 months
|
8.0%
2/25 • Approximately 2 months
|
|
Cardiac disorders
Rapid heartbeat
|
8.3%
2/24 • Approximately 2 months
|
8.0%
2/25 • Approximately 2 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
8.3%
2/24 • Approximately 2 months
|
12.0%
3/25 • Approximately 2 months
|
|
Skin and subcutaneous tissue disorders
Skin itchiness
|
8.3%
2/24 • Approximately 2 months
|
20.0%
5/25 • Approximately 2 months
|
|
Skin and subcutaneous tissue disorders
Skin redness
|
8.3%
2/24 • Approximately 2 months
|
16.0%
4/25 • Approximately 2 months
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
4.2%
1/24 • Approximately 2 months
|
8.0%
2/25 • Approximately 2 months
|
|
General disorders
Sore mouth
|
8.3%
2/24 • Approximately 2 months
|
16.0%
4/25 • Approximately 2 months
|
|
General disorders
Sore throat
|
16.7%
4/24 • Approximately 2 months
|
12.0%
3/25 • Approximately 2 months
|
|
Gastrointestinal disorders
Vomiting or nausea
|
4.2%
1/24 • Approximately 2 months
|
32.0%
8/25 • Approximately 2 months
|
|
General disorders
Weakness
|
16.7%
4/24 • Approximately 2 months
|
32.0%
8/25 • Approximately 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place