The Families Addressing Cancer Together Intervention for Parents With Cancer

NCT05377749 | Completed Results DMC

• 2 other identifiers: LCCC21505K07CA218167
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed pilot randomized controlled trial will test the FACT (Families Addressing Cancer Together) intervention designed to improve parents' confidence and ability to talk about their cancer with their minor children. We will enroll 40 patients with cancer who have a minor child to participate in this single site, 6-week study. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible and acceptable when compared with a wait-list control condition.

Conditions

Neoplasms; Cancer; Parenting; Communication; Parents; Parent-Child Relations

Outcome Measures

Primary Outcomes (3)

• Families Addressing Cancer Together (FACT) Satisfaction Scale

  Acceptability was measured by the FACT satisfaction scale in the intervention group using the study-specific, 6-item FACT satisfaction scale. The total score range is 0-18 with higher scores indicating more satisfaction.

  3 weeks

• Acceptability as Measured by FACT Satisfaction Scale

  Satisfaction with FACT will be measured in the intervention group using the study-specific, 6-item FACT satisfaction scale. Total score range is 0-18 with higher scores indicating more satisfaction.

  6 weeks

• Acceptability as Assessed by a Semi-structured, Post-intervention Interview

  Satisfaction with FACT will be assessed via semi-structured, post-intervention interviews. Regarding n's, these interviews were offered as an optional part of participation among those randomized to the intervention (FACT). 12 participants agreed to participate in the interviews.

  6 weeks

Secondary Outcomes (5)

• Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation

  6 weeks

• Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey

  3 weeks

• Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.

  6 weeks

• Change From Baseline Communication Self-efficacy Using the CSES

  Baseline, 3 weeks

• Change From Baseline Communication Self-efficacy Using the CSES

  Baseline, 6 weeks

Study Arms (2)

FACT intervention

EXPERIMENTAL

Families Addressing Cancer Together (FACT) intervention plus questionnaires

Behavioral: FACT

Wait-list control condition

NO INTERVENTION

Participants assigned to the waitlist control condition only complete questionnaires during the study period. After they have completed their 6-week study activities, they will receive access to the FACT intervention.

Interventions

FACT BEHAVIORAL

Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.

FACT intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent reviewed and signed;
• Age equal to or above 18 years;
• Ability to understand and comply with study procedures;
• Able to complete all study measures and visits in English;
• Be a parent (defined as biological, adoptive, foster, or step-parent), kin caregiver (defined as a relative or someone with a significant emotional relationship who provides full-time care and nurturing of a child), or legal guardian of a child age 3 to 17 years of age who can speak and understand English;
• Have a diagnosis of Stage II-IV (or equivalent) invasive solid tumor not in surveillance or survivorship

You may not qualify if:

• Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
• Prior participation in the pilot trial or development and user testing protocol preliminary to this study;
• No current or expected contact with their child; or
• Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Neoplasms; Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Zev Nakamura, MD
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

zev_nakamura@med.unc.edu

(984) 974-3829

Study Officials

• Zev M Nakamura, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Biostatistician
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 17, 2022
• Study Start: July 5, 2022
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: May 23, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)