NCT05048316

Brief Summary

Investigators will test an evidence-based behavioral intervention that is responsive to Young Adults (YA's) expressed needs and priorities

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

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

May 11, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2022

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

August 31, 2021

Last Update Submit

April 13, 2023

Conditions

Cancer SurvivorYoung Adult

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    Immediately after the intervention

  • Session attendance after the intervention - Acceptability

    Videoconference delivery will be acceptable if average group attendance is ≥6/10 sessions.

    Immediately after the intervention

Secondary Outcomes (2)

  • Quality of life before intervention

    Baseline

  • Change in quality of life at after intervention

    Immediately after intervention

Other Outcomes (8)

  • Symptom burden before intervention

    Baseline

  • Change in Symptom burden after intervention

    Immediately after intervention

  • Cancer-related distress before intervention

    Baseline

  • +5 more other outcomes

Study Arms (1)

eHealth

EXPERIMENTAL

Weekly video conference groups led by a trained facilitator

Behavioral: Cognitive-Behavioral Stress Management and Health Education

Interventions

Cognitive-Behavioral Stress Management and Health EducationBEHAVIORAL

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.

eHealth

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Metastatic disease
  • Continued cancer treatment
  • Psychiatric or neurological disorders that could interfere with study participation
  • Vulnerable populations will not be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, 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.

    PMID: 40879639DERIVED

  • Oswald 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.

    PMID: 36229547DERIVED

Related Links

Study Officials

  • Laura Oswald, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 17, 2021

Study Start

May 11, 2021

Primary Completion

January 6, 2022

Study Completion

January 6, 2022

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)