Cancer SurvivorNCT02832154

Internet-Delivered Positive Affect Program in Managing Emotion in Young Adult Cancer Survivors

A study testing Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Cancer Survivor, run by Wake Forest University Health Sciences at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This pilot clinical trial studies how well an internet-delivered positive affect (PA) intervention works in managing emotion in young adult cancer survivors. An internet-delivered PA intervention may teach younger cancer survivors healthy coping skills and help doctors to learn more about what effects mood may have on… Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Cancer Survivor
What is being tested?: Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 2 sitesUnited States
Study dates: 21 Apr 2017to 23 Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Able to read and understand English
Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
18 to 39 years of age at diagnosis
Within 0-5 years post-active treatment
Wireless internet connection or a home computer that is connected to the internet

Who cannot join

Evidence of a cancer recurrence
History of multiple primary cancers
Currently receiving palliative or hospice care
Significant psychiatric history

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Northwestern University
Chicago, Illinois, 60611
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Enhancing Management of Patient Reported Outcomes With Emotion Regulation (EMPOWER)

Read the detailed description

PRIMARY OBJECTIVES:

To adapt an individualized positive affect intervention that was developed for newly diagnosed HIV patients to use with young adult cancer survivors.

II. To pilot test the positive affect intervention with young adult cancer survivors to determine its feasibility and acceptability.

SECONDARY OBJECTIVES:

To describe health related quality of life, psychological well-being, daily emotion reports, and health behaviors in young adult cancer survivors.

OUTLINE:

Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.

After completion of study, patients are followed up at 1 and 12 weeks.

Conditions: Cancer Survivor
Being tested: Internet-Based Intervention, Quality-of-Life Assessment, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Internet-Based InterventionOther
Complete online PA program
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT02832154
Study group	Role	What they receive
Supportive Care	Experimental	Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises. Receives: Other: Internet-Based Intervention; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability - Mean Value
Quantitative measures and interview will be used to quantify acceptability. The mean of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?
Measured: At 12 weeks
Acceptability - Proportion Value
Quantitative measures and interview will be used to quantify acceptability. The proportion of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Responding affirmatively means a score of 9 or 10 on the scale of 0-10, so the proportion responding affirmatively is the proportion of patients who responded with a 9 or 10 to those questions. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?
Measured: At 12 weeks
Accrual
Accrual will be estimated as the number of patients accrued divided by the number of months of accrual. A 95% confidence interval for the monthly accrual rate will be calculated based on the Poisson distribution.
Measured: Up to 19 months
Adherence - Proportion of Completed Interventions (Mean Value)
Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the mean adherence across all individuals who completed three or more sessions.
Measured: At 12 weeks
Adherence - Proportion of Completed Interventions (Proportion Value)
Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the proportion of patients who completed three or more sessions.
Measured: At 12 weeks
Number of Patients Who Refused to Participate
The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible.
Measured: At 12 weeks
Number of Patient Provided Data at 8 Weeks - Retention
Retention will be defined as the proportion of patients who provide 8 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by site
Measured: At 8 week
Adherence - Number of Completed Exercises
Adherence to the intervention will be calculated as the frequency of completing exercises. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.
Measured: At 12 weeks
Number of Website Visits
Adherence to the intervention will be calculated as the number of website visits. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.
Measured: At 12 weeks
Number of Patients Provided Data at 12 Weeks - Retention
Retention will be defined as the number of patients who provide 12 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.
Measured: At 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 201723 Apr 2020

First posted14 Jul 2016 (estimated)
Study start21 Apr 2017
Primary completion23 Apr 2019
Study completion23 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cancer SurvivorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02832154
Sponsor's protocol ID: IRB00037913
Other IDs: NCI-2016-00647, CCCWFU 99516, P30CA012197, R01MH084723
Status last verified: Jul 2020
First submitted: 20 May 2016
Last updated: 16 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Salsman JM, McLouth LE, Tooze JA, Little-Greene D, Cohn M, Kehoe MS, Moskowitz JT. An eHealth, Positive Emotion Skills Intervention for Enhancing Psychological Well-Being in Young Adult Cancer Survivors: Results from a Multi-Site, Pilot Feasibility Trial. Int J Behav Med. 2023 Oct;30(5):639-650. doi: 10.1007/s12529-023-10162-5. Epub 2023 Mar 8.
PubMed 36890329
Salsman JM, McLouth LE, Cohn M, Tooze JA, Sorkin M, Moskowitz JT. A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2020 May 28;9(5):e17078. doi: 10.2196/17078.
PubMed 32463014

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Management of Patient Reported Outcomes With Emotion Regulation (EMPOWER)
ClinicalTrials.gov ID: NCT02832154
Acronym / sponsor ID: IRB00037913
Conditions: Cancer Survivor
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), National Institute of Mental Health (NIMH)
Study start: 21 Apr 2017 (actual)
Primary completion: 23 Apr 2019 (actual)
Study completion: 23 Apr 2020 (actual)
First posted: 14 Jul 2016 (estimated)
Results: Posted 16 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To adapt an individualized positive affect intervention that was developed for newly diagnosed HIV patients to use with young adult cancer survivors.

II. To pilot test the positive affect intervention with young adult cancer survivors to determine its feasibility and acceptability.

SECONDARY OBJECTIVES:

To describe health related quality of life, psychological well-being, daily emotion reports, and health behaviors in young adult cancer survivors.

OUTLINE:

After completion of study, patients are followed up at 1 and 12 weeks.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Supportive Care	Experimental	Other: Internet-Based Intervention, Procedure: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Able to read and understand English
Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
18 to 39 years of age at diagnosis
Within 0-5 years post-active treatment
Wireless internet connection or a home computer that is connected to the internet

Key exclusion criteria (4 listed)

Evidence of a cancer recurrence
History of multiple primary cancers
Currently receiving palliative or hospice care
Significant psychiatric history

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Internet-Based InterventionComplete online PA program	Other	Supportive Care
Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Procedure or surgery	Supportive Care
Questionnaire AdministrationAncillary studies	Other	Supportive Care

Primary outcome

Acceptability - Mean Value
Time frame: At 12 weeks
Quantitative measures and interview will be used to quantify acceptability. The mean of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?
Acceptability - Proportion Value
Time frame: At 12 weeks
Quantitative measures and interview will be used to quantify acceptability. The proportion of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Responding affirmatively means a score of 9 or 10 on the scale of 0-10, so the proportion responding affirmatively is the proportion of patients who responded with a 9 or 10 to those questions. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?
Accrual
Time frame: Up to 19 months
Accrual will be estimated as the number of patients accrued divided by the number of months of accrual. A 95% confidence interval for the monthly accrual rate will be calculated based on the Poisson distribution.
Adherence - Proportion of Completed Interventions (Mean Value)
Time frame: At 12 weeks
Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the mean adherence across all individuals who completed three or more sessions.
Adherence - Proportion of Completed Interventions (Proportion Value)
Time frame: At 12 weeks
Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the proportion of patients who completed three or more sessions.
Number of Patients Who Refused to Participate
Time frame: At 12 weeks
The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible.
Number of Patient Provided Data at 8 Weeks - Retention
Time frame: At 8 week
Retention will be defined as the proportion of patients who provide 8 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by site
Adherence - Number of Completed Exercises
Time frame: At 12 weeks
Adherence to the intervention will be calculated as the frequency of completing exercises. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.
Number of Website Visits
Time frame: At 12 weeks
Adherence to the intervention will be calculated as the number of website visits. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.
Number of Patients Provided Data at 12 Weeks - Retention
Time frame: At 12 weeks
Retention will be defined as the number of patients who provide 12 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.

Results and safety

Results posted to the registry on 16 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Supportive Care	43	43

Primary outcome: Acceptability - Mean Value

Time frame: At 12 weeks. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Supportive Care n = 26
Value	8.81 (8.27 to 9.34)

Population analysed: Only 26 participants out of the 43 were analyzed for acceptability for this outcome.

Primary outcome: Acceptability - Proportion Value

Time frame: At 12 weeks. Number (95% Confidence Interval). Unit: proportion of participants

Measure	Supportive Care n = 26
Value	0.58 (0.37 to 0.77)

Population analysed: Only 26 participants out of the 43 were analyzed for acceptability for this outcome.

Primary outcome: Accrual

Time frame: Up to 19 months. Mean (95% Confidence Interval). Unit: participants per month

Measure	Supportive Care n = 43
Value	1.63 (1.18 to 2.19)

Primary outcome: Adherence - Proportion of Completed Interventions (Mean Value)

Time frame: At 12 weeks. Mean (Standard Deviation). Unit: completed interventions

Measure	Supportive Care n = 43
Value	3.30 (2.20)

Adverse events

Time frame: Up to 19 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Supportive Care	0 of 0	0 of 0	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36890329Salsman JM, McLouth LE, Tooze JA, Little-Greene D, Cohn M, Kehoe MS, Moskowitz JT. An eHealth, Positive Emotion Skills Intervention for Enhancing Psychological Well-Being in Young Adult Cancer Survivors: Results from a Multi-Site, Pilot Feasibility Trial. Int J Behav Med. 2023 Oct;30(5):639-650. doi: 10.1007/s12529-023-10162-5. Epub 2023 Mar 8.
Derived from this study: PubMed 32463014Salsman JM, McLouth LE, Cohn M, Tooze JA, Sorkin M, Moskowitz JT. A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2020 May 28;9(5):e17078. doi: 10.2196/17078.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Salsman principal investigator

Wake Forest University Health Sciences

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability - Mean Value (time frame: At 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02832154, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.