Cancer Parenting Program for the Enhancement of the Quality of Life of Patients With Advanced Cancer and Their Children (EC-PC)

University of Washington

Status: Terminated

Conditions: Parenting; Survivorship; Parent-Child Relations; Cancer; Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

Treatments: Other: Educational Intervention; Other: Questionnaire Administration; Other: Informational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05477784

RG1122669

R01NR019987-01A1 (U.S. NIH Grant/Contract)

NCI-2022-08714 (Registry Identifier)

STUDY00011221

Details and patient eligibility

About

This trial examines the usefulness of two educational programs for parents with late-stage cancer who have a 5 - 17 year old child. The programs are designed to enhance the quality of the parent-child relationship and add to the parent's confidence in managing the impact of their cancer on their child. Educational programs may reduce anxiety and depression and improve the well-being and quality of life of parents with advanced cancers and their children.

Recruitment occurs nationally via referral to the Fred Hutch/University of Washington Cancer Consortium team.

Full description

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (ENHANCING CONNECTIONS-PALLIATIVE CARE [EC-PC] PROGRAM): Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child.

GROUP II (CONTROL): Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study.

Enrollment: 174 patients

Sex: All

Ages: 23 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parents with any type of late-stage, non-curable cancer (determined by TNM stage IV cancer for solid tumors or 2 or more cycles of treatment failure with disease relapse in non-solid tumors)
• All therapies are allowable
• 23 years (yr.) to 68 yr. Age restriction exists for the patient based on parent having a child ages 5-17
• Patient must have a child (5yr. -17 yr.) living in the home at least 50% of the time and residential with non-ill parent or parent surrogate
• Read and write English as one of their languages of choice
• Have access to a telephone
• Ability to understand and the willingness to sign a written informed consent document. Read and write English as one of their languages of choice

Exclusion criteria

• Patient is in hospice at time of enrollment
• Non-ill co-parent does not consent to join study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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174 participants in 2 patient groups

Group I (enhancing connections-palliative care program)

Experimental group

Description:

Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child.

Treatment:

Other: Questionnaire Administration

Other: Educational Intervention

Group II (educational material)

Active Comparator group

Description:

Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study.

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration