Developing and Pre-Testing an eHealth Group Intervention for Young Adult Cancer Survivors

NCT ID: NCT05054569

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2021-12-15

Brief Summary

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The purpose of this study is to develop and pre-test an eHealth group intervention for young adult cancer survivors.

Detailed Description

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In the first part of this study, the investigators adapted an evidence-based intervention for improving HRQOL to better meet the needs of young adult cancer survivors, and then conducted focus groups with young adult cancer survivors to get feedback on the adapted intervention. In the second part of the study, the investigators will conduct a single-arm pilot trial in which the adapted intervention will be delivered over videoconference via weekly group meetings with a trained facilitator over the course of 10 weeks.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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10-week eHealth intervention

Weekly video conference groups led by a trained facilitator

Group Type EXPERIMENTAL

Cognitive-Behavioral Stress Management and Health Education

Intervention Type BEHAVIORAL

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.

Interventions

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Cognitive-Behavioral Stress Management and Health Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age 18-39 years at the time of participation
* diagnosed with a non-metastatic primary cancer between 18-39 years old
* completed primary cancer treatment (excepting hormone therapy) 1 month to 5 years prior to enrollment
* able to speak and read English
* access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences

Exclusion Criteria

* metastatic disease
* psychiatric or neurological disorders that could interfere with study participation
* considered part of a vulnerable population
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Rina Fox

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40879639 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36229547 (View on PubMed)

Other Identifiers

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IRG-18-163-24

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU00214055

Identifier Type: OTHER

Identifier Source: secondary_id

NU 20CC18

Identifier Type: -

Identifier Source: org_study_id

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