NCT05952492

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

January 16, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

July 11, 2023

Last Update Submit

November 22, 2024

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility of recruitment of young adult cancer survivors

    Recruitment will be considered feasible if ≥40% of eligible survivors enroll in the study.

    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

    Baseline and immediately after the intervention

  • Change in stress management self-efficacy skills from baseline to immediately after the intervention

    Baseline and immediately after the intervention

  • Change in cancer-related distress from baseline to immediately after the intervention

    Baseline and immediately after the intervention

  • Change in coping from baseline to immediately after the intervention

    Baseline and immediately after the intervention

  • Change in anxiety symptoms from baseline to immediately after the intervention

    Baseline and immediately after the intervention.

  • +2 more secondary outcomes

Study Arms (1)

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.

Behavioral: Stress Management Skills Training

Interventions

Stress Management Skills TrainingBEHAVIORAL

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.

Stress Management Skills Training

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \) Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Related Publications (1)

  • 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.

    PMID: 40879639DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Rina Fox, PhD, MPH

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

January 16, 2024

Primary Completion

August 15, 2024

Study Completion

October 30, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)