Trial Outcomes & Findings for Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. (NCT NCT06029907)
NCT ID: NCT06029907
Last Updated: 2026-08-25
Results Overview
Participants will be asked if they found the intervention helpful on follow-up surveys. This will serve as the acceptability benchmark.
COMPLETED
PHASE4
21 participants
6 months post-intervention, specifically at 9 months
2026-08-25
Participant Flow
Participant milestones
| Measure |
Study Population
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.
Baseline characteristics by cohort
| Measure |
Study Population
n=21 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
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Age, Continuous
|
58 years
STANDARD_DEVIATION 11 • n=31 Participants
|
|
Sex/Gender, Customized
Sex · Male
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5 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Sex · Female
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14 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Sex · Unknown/Not Reported
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Black
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8 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
10 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaskan Native
|
2 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 6 months post-intervention, specifically at 9 monthsCompleting study participation is the number of those who attend all sessions and complete follow-up surveys. This will serve as the feasibility benchmark.
Outcome measures
| Measure |
Study Population
n=19 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Number of Participants Who Complete the Study
|
14 Participants
|
PRIMARY outcome
Timeframe: 6 months post-intervention, specifically at 9 monthsParticipants will be asked if they found the intervention helpful on follow-up surveys. This will serve as the acceptability benchmark.
Outcome measures
| Measure |
Study Population
n=19 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Number of Participants Who Report That the Intervention Was Helpful
|
15 Participants
|
SECONDARY outcome
Timeframe: 6 months post-intervention, specifically at 9 monthsPopulation: Participants with data collected.
Biochemically verified 7-day point prevalence smoking abstinence with use of CO (carbon monoxide) monitors.
Outcome measures
| Measure |
Study Population
n=17 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Number of Participants With Validated Cessation
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, post-treatment (3 months), 6-month follow-upPopulation: Participants with data collected at each timepoint.
Patients will report their pain on a scale from 0-10 \[0 being "no pain" and 10 being "pain as bad as you can imagine"\] on administered surveys at baseline, post-intervention, and 3-month post-intervention. Study team will look to see if there is a change in patient-reported pain.
Outcome measures
| Measure |
Study Population
n=20 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Patient-reported Pain Severity
Baseline
|
4.7 score on a scale
Standard Deviation 2.2
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|
Patient-reported Pain Severity
3 months
|
4.8 score on a scale
Standard Deviation 2.0
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Patient-reported Pain Severity
6 months
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5.5 score on a scale
Standard Deviation 2.7
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SECONDARY outcome
Timeframe: Baseline, post-treatment (3 months), 6-month follow-upPopulation: Participants with data collected at each timepoint.
Patients will report how pain is affecting their lives 0-10 \[0 being "does not interfere" and 10 being "completely interferes"\] on administered surveys.
Outcome measures
| Measure |
Study Population
n=19 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Patient-reported Pain Interference
Baseline
|
5.0 score on a scale
Standard Deviation 2.5
|
|
Patient-reported Pain Interference
3 months
|
4.8 score on a scale
Standard Deviation 2.1
|
|
Patient-reported Pain Interference
6 months
|
6.2 score on a scale
Standard Deviation 2.7
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SECONDARY outcome
Timeframe: Baseline, post-treatment (3 months), 6-month follow-upPopulation: Participants with data collected at each timepoint.
Patients will report their ability to stop smoking on administered surveys at baseline, post-intervention, and 6 months post-intervention. Smoking self-efficacy is measured on a scale from 1 to 7 where 1 is "not confident at all" and 7 is "extremely confident". Study team will look to see if there is a change in patient-reported self-efficacy.
Outcome measures
| Measure |
Study Population
n=19 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Change in Patient-reported Smoking Cessation Self-efficacy
Baseline
|
5.2 score on a scale
Standard Deviation 1.6
|
|
Change in Patient-reported Smoking Cessation Self-efficacy
3 months
|
3.8 score on a scale
Standard Deviation 2.3
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|
Change in Patient-reported Smoking Cessation Self-efficacy
6 months
|
3.8 score on a scale
Standard Deviation 1.9
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SECONDARY outcome
Timeframe: Baseline, post-treatment (3 months), 6-month follow-upPopulation: Participants with data collected at each timepoint.
Patients will report their ability to manage their pain on administered surveys at baseline, post-intervention, and 6 months post-intervention. Pain management self-efficacy is measured on a scale of 1-10 where 1 is "very uncertain, 5 is "moderately uncertain", and 10 is "very uncertain". The total score ranges from 7 to 70, where higher scores indicate greater self-efficacy and confidence in managing daily life with pain.
Outcome measures
| Measure |
Study Population
n=19 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Change in Patient-reported Pain Management Self-efficacy
Baseline
|
54.1 score on a scale
Standard Deviation 24.8
|
|
Change in Patient-reported Pain Management Self-efficacy
3 months
|
54.5 score on a scale
Standard Deviation 12.1
|
|
Change in Patient-reported Pain Management Self-efficacy
6 months
|
61.2 score on a scale
Standard Deviation 22.5
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SECONDARY outcome
Timeframe: Baseline, post-intervention (3 months), 6-month follow-upPopulation: Participants with data collected at each timepoint.
Patients will respond to questions about their perceived quality of life on administered surveys at baseline, 3 months post-intervention, and 6 months post-intervention. Quality of life will be measured based on questions related to Depression/Mood/Negative Affect (Hospital Anxiety Depression Scale - HADS). The Anxiety subscale has a score ranging from 0-21, where higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Study Population
n=15 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Change in Patient-reported Quality of Life as Measured by the Hospital Anxiety Depression Scale (HADS) - Anxiety
Baseline
|
9.0 score on a scale
Standard Deviation 4.1
|
|
Change in Patient-reported Quality of Life as Measured by the Hospital Anxiety Depression Scale (HADS) - Anxiety
3 months
|
8.2 score on a scale
Standard Deviation 3.0
|
|
Change in Patient-reported Quality of Life as Measured by the Hospital Anxiety Depression Scale (HADS) - Anxiety
6 months
|
11.5 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (3 months), 6-month follow-upPopulation: Participants with data collected at each timepoint.
Patients will respond to questions about their perceived quality of life on administered surveys at baseline, 3 months post-intervention, and 6 months post-intervention. Quality of life will be measured based on questions related to Depression/Mood/Negative Affect (Hospital Anxiety Depression Scale - HADS). The Depression subscale has a score ranging from 0-21, where higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Study Population
n=19 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Change in Patient-reported Quality of Life as Measured by the Hospital Anxiety Depression Scale (HADS) - Depression
Baseline
|
7.7 score on a scale
Standard Deviation 4.4
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|
Change in Patient-reported Quality of Life as Measured by the Hospital Anxiety Depression Scale (HADS) - Depression
3 months
|
8.2 score on a scale
Standard Deviation 4.1
|
|
Change in Patient-reported Quality of Life as Measured by the Hospital Anxiety Depression Scale (HADS) - Depression
6 months
|
7.0 score on a scale
Standard Deviation 1.2
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SECONDARY outcome
Timeframe: Baseline, post-intervention (3 months), 6-month follow-upPopulation: Participants with data collected at each timepoint.
Patients will respond to questions about their perceived quality of life on administered surveys at baseline, post-intervention, and 6 months post-intervention. Quality of life will be measured based on questions from the Coping subscale of the Rhode Island Stress and Coping Inventory. Patients will answer five questions on scale from 1 = "never" to 5 = "most of the time" and is reported as an average score. Higher scores indicate stronger coping capabilities.
Outcome measures
| Measure |
Study Population
n=19 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Change in Patient-reported Quality of Life as Measured by the Rhode Island Stress and Coping Inventory - Coping
Baseline
|
2.5 score on a scale
Standard Deviation 1.0
|
|
Change in Patient-reported Quality of Life as Measured by the Rhode Island Stress and Coping Inventory - Coping
3 months
|
3.0 score on a scale
Standard Deviation 0.7
|
|
Change in Patient-reported Quality of Life as Measured by the Rhode Island Stress and Coping Inventory - Coping
6 months
|
3.0 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (3 months), 6-month follow-upPopulation: Participants with data collected at each timepoint.
Patients will respond to questions about their perceived quality of life on administered surveys at baseline, post-intervention, and 6 months post-intervention. Quality of life will be measured based on questions related to Physical Well Being. Patients will answer questions on a 5-point scale from 0 = "not at all" to 4 = "very much". A higher score indicates worse well being.
Outcome measures
| Measure |
Study Population
n=17 Participants
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
Change in Patient-reported Quality of Life - Physical Well Being
Baseline
|
1.7 score on a scale
Standard Deviation 0.8
|
|
Change in Patient-reported Quality of Life - Physical Well Being
3 months
|
1.6 score on a scale
Standard Deviation 0.6
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|
Change in Patient-reported Quality of Life - Physical Well Being
6 months
|
1.6 score on a scale
Standard Deviation 1.0
|
Adverse Events
Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Population
n=21 participants at risk
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Smoking cessation and pain management intervention: Patients will receive a behavioral smoking cessation and pain management intervention
Varenicline: Patients will receive varenicline prescribed by their oncologist
|
|---|---|
|
General disorders
Nausea
|
4.8%
1/21 • 6 months post-intervention, specifically at 9 months
|
|
General disorders
Insomnia
|
4.8%
1/21 • 6 months post-intervention, specifically at 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place