Cancer SurvivorNCT05048316
Study to Develop a Group-Based E-Health Intervention for YA Cancer Survivors
A study testing Cognitive-Behavioral Stress Management and Health Education in people with Cancer Survivor and Young Adult, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
Investigators will test an evidence-based behavioral intervention that is responsive to Young Adults (YA's) expressed needs and priorities Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivor, Young Adult
- What is being tested?
- Cognitive-Behavioral Stress Management and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2021to 6 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-39 years old
- Diagnosed with cancer between 18-39 years old
- Cancer diagnosis was non-metastatic
- Completed cancer treatment between 1 month and 5 years prior to enrollment, with the exception of ongoing hormone therapy
- No documented or observable psychiatric or neurological disorders that could interfere with participation (e.g., active psychosis, active substance abuse), as identified by the referring medical team, chart review, or screening
- Able to speak and read English
- Able to provide informed consent
Who cannot join
- Metastatic disease
- Continued cancer treatment
- Psychiatric or neurological disorders that could interfere with study participation
- Vulnerable populations will not be included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Develop a Group-Based E-Health Intervention for Young Adult Cancer Survivors
Investigators will test an evidence-based behavioral intervention that is responsive to Young Adults (YA's) expressed needs and priorities
- Conditions
- Cancer Survivor, Young Adult
- Being tested
- Cognitive-Behavioral Stress Management and Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Stress Management and Health EducationBehavioural
Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.
| Study group | Role | What they receive |
|---|---|---|
| eHealth | Experimental | Weekly video conference groups led by a trained facilitator Receives: Behavioral: Cognitive-Behavioral Stress Management and Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction assessed by study-specific survey during the intervention - Acceptability
The intervention will be deemed acceptable if, on average, participants report satisfaction with the weekly sessions as ≥2 on a 0-4 scale.
Measured: During intervention
Satisfaction assessed by study-specific survey after the intervention - Acceptability
The intervention will be deemed acceptable if, on average, participants report satisfaction with the overall program and intent to continue using the intervention skills as ≥2 on a 0-4 scale.
Measured: Immediately after the intervention
Session attendance after the intervention - Acceptability
Videoconference delivery will be acceptable if average group attendance is ≥6/10 sessions.
Measured: Immediately after the intervention
Secondary outcomes (2)
Quality of life before intervention
Participants will complete the 27-item Functional Assessment of Cancer Therapy - General
Measured: Baseline
Change in quality of life at after intervention
Participants will complete the 27-item Functional Assessment of Cancer Therapy - General
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start11 May 2021
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Oswald, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048316
- Sponsor's protocol ID
- MCC-21053
- Status last verified
- Apr 2023
- First submitted
- 31 Aug 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fox RS, Badger TA, Moya S, Gudenkauf LM, Nelson MA, O'Neill RM, Leete JJ, Friedman SE, Katsanis E, Victorson DE, Sanford SD, Penedo FJ, Antoni MH, Oswald LB. An HRQOL Proof-Of-Concept Analysis of the eHealth TOGETHER Intervention for Adolescent and Young Adult Cancer Survivors: A Brief Report. Psychooncology. 2025 Jul;34(7):e70234. doi: 10.1002/pon.70234.
PubMed 40879639Oswald LB, Lyleroehr M, Gudenkauf LM, Armstrong GE, Tometich DB, Sanford SD, Loecher N, Geiss C, Rodriguez Y, Scheel KL, Nieves-Lopez A, Jim HSL, Gonzalez BD, Antoni MH, Penedo FJ, Reed D, Katsanis E, Salsman JM, Victorson D, Fox RS. Development and initial testing of TOGETHER-YA: an eHealth-delivered and group-based psychosocial intervention for young adult cancer survivors. Support Care Cancer. 2022 Dec;30(12):10067-10076. doi: 10.1007/s00520-022-07382-y. Epub 2022 Oct 14.
PubMed 36229547
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Develop a Group-Based E-Health Intervention for Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05048316
- Acronym / sponsor ID
- MCC-21053
- Conditions
- Cancer Survivor, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will test an evidence-based behavioral intervention that is responsive to Young Adults (YA's) expressed needs and priorities
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eHealth | Experimental | Behavioral: Cognitive-Behavioral Stress Management and Health EducationWeekly video conference groups led by a trained facilitator |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-39 years old
- Diagnosed with cancer between 18-39 years old
- Cancer diagnosis was non-metastatic
- Completed cancer treatment between 1 month and 5 years prior to enrollment, with the exception of ongoing hormone therapy
- No documented or observable psychiatric or neurological disorders that could interfere with participation (e.g., active psychosis, active substance abuse), as identified by the referring medical team, chart review, or screening
Key exclusion criteria (4 listed)
- Metastatic disease
- Continued cancer treatment
- Psychiatric or neurological disorders that could interfere with study participation
- Vulnerable populations will not be included
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 |
|---|---|---|
| Cognitive-Behavioral Stress Management and Health EducationParticipants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content. | Behavioural | eHealth |
Primary outcome
Satisfaction assessed by study-specific survey during the intervention - Acceptability
Time frame: During intervention
The intervention will be deemed acceptable if, on average, participants report satisfaction with the weekly sessions as ≥2 on a 0-4 scale.
Satisfaction assessed by study-specific survey after the intervention - Acceptability
Time frame: Immediately after the intervention
The intervention will be deemed acceptable if, on average, participants report satisfaction with the overall program and intent to continue using the intervention skills as ≥2 on a 0-4 scale.
Session attendance after the intervention - Acceptability
Time frame: Immediately after the intervention
Videoconference delivery will be acceptable if average group attendance is ≥6/10 sessions.
2 secondary outcomes
Quality of life before intervention
Time frame: Baseline
Change in quality of life at after intervention
Time frame: Immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Derived from this study: PubMed 40879639Fox RS, Badger TA, Moya S, Gudenkauf LM, Nelson MA, O'Neill RM, Leete JJ, Friedman SE, Katsanis E, Victorson DE, Sanford SD, Penedo FJ, Antoni MH, Oswald LB. An HRQOL Proof-Of-Concept Analysis of the eHealth TOGETHER Intervention for Adolescent and Young Adult Cancer Survivors: A Brief Report. Psychooncology. 2025 Jul;34(7):e70234. doi: 10.1002/pon.70234.
- Derived from this study: PubMed 36229547Oswald LB, Lyleroehr M, Gudenkauf LM, Armstrong GE, Tometich DB, Sanford SD, Loecher N, Geiss C, Rodriguez Y, Scheel KL, Nieves-Lopez A, Jim HSL, Gonzalez BD, Antoni MH, Penedo FJ, Reed D, Katsanis E, Salsman JM, Victorson D, Fox RS. Development and initial testing of TOGETHER-YA: an eHealth-delivered and group-based psychosocial intervention for young adult cancer survivors. Support Care Cancer. 2022 Dec;30(12):10067-10076. doi: 10.1007/s00520-022-07382-y. Epub 2022 Oct 14.
- Individual participant dataSharing planned: No
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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.
Laura Oswald, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Stress Management and Health Education in people with Cancer Survivor and Young Adult, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 7 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 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satisfaction assessed by study-specific survey during the intervention - Acceptability (time frame: During intervention). The study lists 3 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 NCT05048316, 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 14 Apr 2023.