NCT05597228

Brief Summary

The purpose of this study is to adapt a web-based platform to deliver a group intervention for young adult cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jun 2022

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

Study Start

First participant enrolled

June 9, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

September 21, 2022

Last Update Submit

August 15, 2024

Conditions

Keywords

NeoplasmsQuality of lifeYoung adults

Outcome Measures

Primary Outcomes (3)

  • Satisfaction with the eHealth intervention delivery

    Immediately after the intervention and each week participants will report their satisfaction with the full program through a brief survey.

    At the end of the 10-week intervention, overall and weekly satisfaction scores will be compiled

  • Acceptability of the eHealth intervention delivery

    Immediately after the intervention participants will report their satisfaction with the full program through a brief survey.

    At the end of the 10-week intervention

  • Acceptability of the eHealth intervention delivery

    The number of sessions attended, out of a maximum of 10, will be recorded

    At the end of the 10-week intervention, the number of sessions attended will be recorded

Secondary Outcomes (12)

  • Change in health-related quality of life (HRQOL) 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

  • Change in perceived cognitive function from baseline to immediately after the intervention

    Baseline and immediately after the intervention

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

    Baseline and immediately after the intervention

  • Change in perceived emotional support from baseline to immediately after the intervention

    Baseline and immediately after the intervention

  • +7 more secondary outcomes

Study Arms (1)

Behavioral: Cognitive-Behavioral Stress Management and Health Education

EXPERIMENTAL

Weekly video conference groups led by a trained facilitator

Behavioral: Cognitive-Behavioral Stress Management and Health Education

Interventions

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 Cognitive-Behavioral Stress Management and health education content.

Behavioral: Cognitive-Behavioral Stress Management and Health Education

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 a primary cancer between 18-39 years old
  • Finished cancer treatment with curative intent 1 month to 5 years prior to enrollment (except hormone therapy)
  • NED and no anticipated/scheduled anti-cancer treatments at the time of enrollment (except hormone therapy)
  • Able to speak and read English
  • Able and willing to give informed consent
  • Access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences (Part 2 only)

You may not qualify if:

  • Ongoing or future anti-cancer treatments (beyond hormone therapy) are scheduled or anticipated
  • Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)
  • Vulnerable populations will not be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Related Publications (2)

  • 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.

  • Fox RS, Torres TK, Badger TA, Katsanis E, Yang D, Sanford SD, Victorson DE, Yanez B, Penedo FJ, Antoni MH, Oswald LB. Delivering a Group-Based Quality of Life Intervention to Young Adult Cancer Survivors via a Web Platform: Feasibility Trial. JMIR Cancer. 2024 Dec 4;10:e58014. doi: 10.2196/58014.

MeSH Terms

Conditions

Neoplasms

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

September 21, 2022

First Posted

October 28, 2022

Study Start

June 9, 2022

Primary Completion

April 25, 2023

Study Completion

April 25, 2023

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations