Cancer Within a Pandemic: A Telemental Health Intervention

NCT ID: NCT04659993

Last Updated: 2025-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-06-09

Brief Summary

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The purpose of this research study is to test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer treatment by offering an online support group that teaches healthy coping skills in a practical and acceptable way. Investigators would also like to know if certain parts of the online material is more effective in helping subjects manage their mood.

Detailed Description

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Primary Objective: To improve self-efficacy for young adult cancer survivors navigating pandemic conditions.

Secondary Objective: To reduce depression and anxiety levels through meaning-making.

Conditions

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Cancer Survivorship Depression, Anxiety

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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Telemental Group

The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.

Group Type EXPERIMENTAL

Telemental Health Sessions, Support Groups and Questionnaires

Intervention Type BEHAVIORAL

Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.

Interventions

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Telemental Health Sessions, Support Groups and Questionnaires

Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Documented cancer diagnosis within the Wake Forest Baptist Medical Center medical record;
* Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment);
* Aged 18-39
* Must speak English
* Must have computer with audio and visual capabilities.
* Must live within North Carolina
* Must have experienced health-related anxiety and/or distress in last 3 months.

Exclusion Criteria

* Active inpatient hospitalization
* Major cognitive impairment, marked concerns with working memory, concentration, or word finding difficulties that significantly impairs daily functioning documented in most recent clinic note or self-reported
* Recent suicide attempt(s), psychiatric hospitalization, or psychotic processing (last 3 years)
* Bipolar disorder (I or II) diagnosis, as evidenced by an ICD-10 code within the past year or revealed during subject interview
* Moderate to severe alcohol or drug abuse; as evidenced by an ICD-10 codes related to alcohol or illicit substance abuse in the medical record within the past year or revealed during subject interview.
* Severe eating disorders; as evidenced by an ICD-10 code in the medical record such as anorexia nervosa or bulimia within the past year or revealed during patient interview
* Repeated "acute" crises for example: repeated acute crises consisting of marked psychological distress that impairs function and warrants clinician intervention (e.g., occurring once a month or more frequently); this we be evaluated by the clinician screener.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katie Duckworth, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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WFBCCC01520

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00070150

Identifier Type: -

Identifier Source: org_study_id

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