The Families Addressing Cancer Together Intervention for Parents With Cancer

NCT ID: NCT05377749

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2023-02-22

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.

Detailed Description

Parents with cancer are encouraged to be "honest and open" with their minor children about their illness. However, many lack access to professional support for their communication needs. Without this support, parents with cancer and their children experience avoidable psychosocial distress. In order to better support parental communication needs in cancer, psychosocial interventions that can be implemented across clinical practice settings are needed. To address this gap, we developed and pilot-tested FACT (Families Addressing Cancer Together) - a theory-guided, web-based psycho-educational intervention to help parents with cancer talk about their illness with their children in a developmentally appropriate way.

The proposed pilot randomized controlled trial will test the feasibility and acceptability of the FACT intervention. 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. We will also explore preliminary effects of the intervention on parental communication and psychological outcomes.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

FACT intervention

Families Addressing Cancer Together (FACT) intervention plus questionnaires

Group Type: EXPERIMENTAL

FACT

Intervention Type: BEHAVIORAL

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

Wait-list control condition

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FACT

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zev M Nakamura, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5K07CA218167

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC2150

Identifier Type: -

Identifier Source: org_study_id