CancerNCT05952492
Digital Connections: an EHealth Group Intervention for Young Adult Cancer Survivors
A study testing Stress Management Skills Training in people with Cancer, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of recruiting young adult cancer survivors from across the nation and to explore the impact of an eHealth group intervention on psychosocial health in this population. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer
- What is being tested?
- Stress Management Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 30 Oct 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-39 years at the time of participation
- Diagnosed with any invasive cancer between 15-39 years old
- Finished curative cancer treatment 1 month to 5 years prior to enrollment (except maintenance therapy such as ongoing hormone therapy)
- Currently experiencing at least mild symptoms of depression or anxiety (i.e., score ≥1 on the Patient Health Questionnaire-4)
- Able to speak and read English so all group attendees can communicate in a shared language.
- Able and willing to give informed consent.
- Access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences
Who cannot join
- 1) Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85719
About this study
Official title: Improving Young Adult Cancer Survivors' Mental Health with an EHealth Group Intervention
The purpose of this study is to determine the feasibility of recruiting young adult cancer survivors from across the nation and to explore the impact of an eHealth group intervention on psychosocial health in this population.
Read the detailed description
Study investigators will conduct a single-arm pilot trial in which a 10 week eHealth group intervention will be delivered via a study website. We will use a multi-pronged approach to recruit young adult cancer survivors from across the country. Study participants will attend weekly group meetings with a trained facilitator to receive the manualized intervention over the course of 10 weeks.
- Conditions
- Cancer
- Being tested
- Stress Management Skills Training
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management Skills TrainingBehavioural
Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and be held once weekly for 10 weeks. Sessions will include stress management skills training and health education content.
| Study group | Role | What they receive |
|---|---|---|
| Stress Management Skills Training | Experimental | Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and be held once weekly for 10 weeks. Sessions will include stress management skills training and health education content. Receives: Behavioral: Stress Management Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment of young adult cancer survivors
Recruitment will be considered feasible if ≥40% of eligible survivors enroll in the study.
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Change in health-related quality of life from baseline to immediately after the intervention
Participants will complete the 27-item Functional Assessment of Cancer Therapy - General. Scores range from 0 to 108, with higher scores reflecting better quality of life.
Measured: Baseline and immediately after the intervention
Change in stress management self-efficacy skills from baseline to immediately after the intervention
Participants will complete subscales from the Measure of Current Status. Subscale scores range from 0 to 8, 0 to 12, or 0 to 20 depending on the subscale. Higher scores indicate more of the construct being assessed.
Measured: Baseline and immediately after the intervention
Change in cancer-related distress from baseline to immediately after the intervention
Participants will complete the 22-item Impact of Event Scale-Revised. Scores range from 0 to 88, with higher scores indicating greater cancer-related distress.
Measured: Baseline and immediately after the intervention
Change in coping from baseline to immediately after the intervention
Participants will complete the Brief Coping Orientation to Problems Experienced scale, which yields 14 two-item subscales. Subscale scores range from 2 to 8, with higher scores indicating greater usage of the coping strategy being assessed.
Measured: Baseline and immediately after the intervention
Change in anxiety symptoms from baseline to immediately after the intervention
Participants will complete the Generalized Anxiety Disorder-7. Given the sample size, the investigators will focus on effect sizes rather than statistical significance.
The Unabbreviated scale title is the Generalized Anxiety Disorder-6. Minimum value=0. Maximum value=21. Higher scores=worse.
Measured: Baseline and immediately after the intervention.
Change in depression symptoms from baseline to immediately after the intervention
Participants will complete the Patient Health Questionnaire-9. Given the sample size, the investigators will focus on effect sizes rather than statistical significance.
The Unabbreviated scale title is the Patient Health Questionnaire-9. Minimum value=0. Maximum value=27. Higher scores=worse.
Measured: Baseline and immediately after the intervention.
Change in trend and relative values of time and frequency domain heart rate variability metrics from pre- to post-intervention.
Participants will wear a wearable sensor for at least 1 week.
Measured: Baseline and the final week of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start16 Jan 2024
- Primary completion15 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rina Fox, PhD, MPH, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952492
- Sponsor's protocol ID
- STUDY00003230
- Status last verified
- Nov 2024
- First submitted
- 11 Jul 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 40879639
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Young Adult Cancer Survivors' Mental Health with an EHealth Group Intervention
- ClinicalTrials.gov ID
- NCT05952492
- Acronym / sponsor ID
- STUDY00003230
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 19 Jul 2023 (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.
The purpose of this study is to determine the feasibility of recruiting young adult cancer survivors from across the nation and to explore the impact of an eHealth group intervention on psychosocial health in this population.
Detailed description
Study investigators will conduct a single-arm pilot trial in which a 10 week eHealth group intervention will be delivered via a study website. We will use a multi-pronged approach to recruit young adult cancer survivors from across the country. Study participants will attend weekly group meetings with a trained facilitator to receive the manualized intervention over the course of 10 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 |
|---|---|---|
| Stress Management Skills Training | Experimental | Behavioral: Stress Management Skills TrainingParticipants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and be held once weekly for 10 weeks. Sessions will include stress management skills training and health education content. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18-39 years at the time of participation
- Diagnosed with any invasive cancer between 15-39 years old
- Finished curative cancer treatment 1 month to 5 years prior to enrollment (except maintenance therapy such as ongoing hormone therapy)
- Currently experiencing at least mild symptoms of depression or anxiety (i.e., score ≥1 on the Patient Health Questionnaire-4)
- Able to speak and read English so all group attendees can communicate in a shared language.
Key exclusion criteria (1 listed)
- 1) Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)
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 |
|---|---|---|
| Stress Management Skills TrainingParticipants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and be held once weekly for 10 weeks. Sessions will include stress management skills training and health education content. | Behavioural | Stress Management Skills Training |
Primary outcome
Feasibility of recruitment of young adult cancer survivors
Time frame: Through study completion, an average of 1 year
Recruitment will be considered feasible if ≥40% of eligible survivors enroll in the study.
7 secondary outcomes
Change in health-related quality of life from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change in stress management self-efficacy skills from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change in cancer-related distress from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change in coping from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change in anxiety symptoms from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention.
Change in depression symptoms from baseline to immediately after the intervention
Time frame: Baseline and immediately after the intervention.
Change in trend and relative values of time and frequency domain heart rate variability metrics from pre- to post-intervention.
Time frame: Baseline and the final week of the 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 26 Nov 2024.
- 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.
- 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.
Rina Fox, PhD, MPH principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management Skills Training in people with Cancer, run by University of Arizona 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 1 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 26 Nov 2024. 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?
Feasibility of recruitment of young adult cancer survivors (time frame: Through study completion, an average of 1 year). 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 NCT05952492, which also lists 1 linked publication.
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 26 Nov 2024.