The Families Addressing Cancer Together Intervention for Parents With Cancer (FACT)

UNC Lineberger Comprehensive Cancer Center

Status: Completed

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

Treatments: Behavioral: FACT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05377749

5K07CA218167 (U.S. NIH Grant/Contract)

LCCC2150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

47 participants in 2 patient groups

FACT intervention

Experimental group

Description:

Families Addressing Cancer Together (FACT) intervention plus questionnaires

Treatment:

Behavioral: FACT

Wait-list control condition

No Intervention group

Description:

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.