Parenting Support for Families with Cancer

Overseen By Kathrin Milbury, MA,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-English speakers, No internet access

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program designed to support parents dealing with cancer that has spread or recurred. The goal is to ease parenting worries, improve family communication about cancer, and enhance parents' mental health. Participants will either engage in the new Parenting Support Intervention program or continue with their usual care for comparison. Suitable candidates are parents actively treating a recurring or spreading solid tumor, with children aged 4 to 16 living at home, and who share parenting duties with a partner. As an unphased trial, this study provides a unique opportunity for parents to access potentially beneficial support tailored to their specific challenges.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on parenting support rather than medication changes.

What prior data suggests that this parenting support intervention is safe?

Research has shown that parenting support programs are generally well-received and safe for families dealing with cancer. In past studies, participants found these programs helpful, with many noticing improvements in their quality of life and mental health. For instance, one study found that parents experienced less stress after joining similar support programs.

These results suggest that the parenting support program in this trial will likely be well-accepted and helpful for families. Reports of negative effects from these types of programs, which focus on providing education and communication support rather than medical treatment, have not emerged. While this trial is not a typical drug trial, evidence suggests that joining this kind of program could be a positive experience for both parents and their children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parenting Support Intervention because it offers a tailored approach for families dealing with cancer, focusing on both education and emotional support. Unlike standard care, which often centers solely on medical treatment for the patient, this intervention includes videoconference sessions that provide both patients and their caregivers with practical parenting strategies and emotional guidance. This method aims to improve the overall family dynamic and quality of life, addressing a crucial aspect of living with cancer that traditional treatments might overlook.

What evidence suggests that this parenting support intervention is effective for families with cancer?

Research has shown that parenting support programs can greatly reduce stress for parents, with improvements in 70.4% of cases involving at least one parent. These programs help parents address concerns and improve the mental health of both parents and their children. In this trial, participants in Group I will receive a parenting support intervention, which includes educational material and a videoconference session. Studies have found that such programs can lower anxiety and depression in parents dealing with cancer in the family. They also improve communication between parents and children about cancer, enhancing their overall quality of life. Early results suggest these programs are practical and well-liked by families facing advanced cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Kathrin Milbury, MA,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for parents over 18 with metastatic or recurrent solid tumors, who have at least one child aged 4-12 they're currently living and co-parenting with. They must be able to consent and complete self-reports (no severe cognitive deficits). Both parent and a spousal caregiver must speak English and have internet access.

Inclusion Criteria

Patients must have a spousal caregiver over the age of 18 who co-parents the child(ren) (i.e. share custody) and is willing and able to consent to participate

Patients must have at least one dependent child between the ages of 4 and 12 and currently living with the parent

Patients must be able to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive education materials and attend 2 weekly videoconference intervention sessions over 45 minutes each. Caregivers attend 2 additional weekly intervention sessions.

2 weeks

4 videoconference sessions

Follow-up

Participants are monitored for psychological symptoms, parenting concerns, and healthcare utilization after intervention

12 weeks

Follow-up at 6 and 12 weeks for Trial 1; 12 weeks for Trial 2

What Are the Treatments Tested in This Trial?

Interventions

• Parenting Support Intervention

Trial Overview The study tests a parenting support program aimed at reducing parenting concerns, improving communication about cancer between parents and children, and enhancing parental psychological wellbeing in families dealing with advanced cancer.

How Is the Trial Designed?

Group I: Group I (education material, videoconference session) Experimental Treatment 2 Interventions

Examine the acceptability of a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers (cohort A) and 10 patients with an advanced cancer diagnosis and their family caregivers (cohort B).

Group II: Group II (waitlist control) Active Control 2 Interventions

Participants receive standard of care.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A 4-session intervention designed to improve communication between parents and children dealing with cancer was found to be feasible and acceptable, with a low attrition rate of 6% among the 66 participating parents.

Parents who received the intervention showed significant improvements in communication self-efficacy, reduced communication difficulties, and increased knowledge about age-appropriate communication, suggesting the intervention's effectiveness in enhancing parent-child communication during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a support intervention designed to improve parents' communication with children dealing with parental cancer: a randomized pilot trial. Liénard, A., Lamal, S., Merckaert, I., et al.[2022]

A novel psycho-educational intervention is being developed to support parents with cancer and improve their parenting efficacy while reducing stress, targeting families with children aged 3-12 years.

The intervention, which includes audiovisual resources and support from a clinical psychologist, will be tested for feasibility and acceptability in a pilot study involving 20 parents, aiming to address the psychological needs of families affected by cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for Enhancing Parenting In Cancer (EPIC): development and evaluation of a brief psycho-educational intervention to support parents with cancer who have young children. Stafford, L., Sinclair, M., Turner, J., et al.[2022]

Patients with incurable end-stage cancer and their co-parents express a strong need for tailored parenting support during their health care journey, highlighting the complexity of parenting under such challenging circumstances.

Effective parenting support requires proactive involvement from health professionals and an interdisciplinary approach to address the unique challenges faced by these families, ensuring that their needs are met throughout the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Australian Hospital-Based Parenting Support for Adults with Incurable End-Stage Cancer: Parent Perspectives. Steiner, V., Joubert, L., Shlonsky, A., et al.[2021]

Healthcare professionals recognize that patients with incurable end-stage cancer face significant parenting-related distress, but their support needs are often overlooked in standard care practices.

Barriers such as lack of systematic screening for parenting status, insufficient resources, and psychosocial factors hinder the ability of healthcare providers to offer effective parenting support, highlighting the need for a more holistic approach to patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital Parenting Support for Adults with Incurable End-Stage Cancer: Multidisciplinary Health Professional Perspectives. Steiner, V., Joubert, L., Shlonsky, A., et al.[2021]

The Enhancing Connections cancer parenting program, consisting of 5 sessions, was feasible and well-received by 16 parents diagnosed with non-metastatic cancer, showing significant improvements in parental anxiety, self-efficacy, skills, and parenting quality after the intervention.

This program demonstrates potential benefits for both parents and their school-age children, suggesting that structured support can enhance parenting competencies and positively impact child behavioral-emotional adjustment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot feasibility study of a group-delivered cancer parenting program: Enhancing Connections-Group. Lewis, FM., Zahlis, EH., Shands, ME., et al.[2022]

The Family Support Program effectively helped parents with incurable cancer understand their children's needs and reactions, leading to improved family communication and reduced conflicts during a difficult time.

Parents expressed a strong desire for the Family Support Program to be made available to all families facing terminal cancer, highlighting its importance in providing necessary information and coping strategies for both parents and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' experiences of a Family Support Program when a parent has incurable cancer. Bugge, KE., Helseth, S., Darbyshire, P.[2022]

A review identified ten parenting support interventions for parents with cancer, including four randomized controlled trials, highlighting a variety of therapeutic aims such as enhancing knowledge, emotion regulation, and communication with children.

Despite the existence of these interventions, there is a significant need for more research to assess their efficacy and to develop comprehensive support programs that address the diverse needs of parents and their children affected by cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to support parenting in patients with cancer and co-parents? From research to practice. Liénard, A., Lamal, S., Merckaert, I.[2023]

Parents with cancer face significant challenges in balancing their illness with parenting responsibilities, highlighting the need for tailored support systems.

Effective support strategies should include access to childcare, home healthcare, and transportation, as well as improved scheduling of medical appointments to accommodate family needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balancing Illness and Parental Demands: Coping With Cancer While Raising Minor Children. Rashi, C., Wittman, T., Tsimicalis, A., et al.[2015]

A systematic review identified 22 different psychosocial interventions aimed at helping parents with cancer manage parenting distress, highlighting the importance of support for families during such challenging times.

While these interventions were generally beneficial and well-received by parents, only a few had undergone thorough evaluation, indicating a need for more rigorous studies to assess their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial interventions targeting parenting distress among parents with cancer - A systematic review and narrative synthesis of available interventions. Romare Strandh, M., Hovén, E., Sörensdotter, R., et al.[2023]

A novel parent support program for advanced cancer patients and their spouses showed promising feasibility, with a 61% consent rate and high attendance (90%) at all sessions, indicating strong engagement with the intervention.

Significant improvements were observed in parenting concerns and efficacy for both patients and spouses at six and twelve weeks post-intervention, suggesting that the program may effectively reduce psychological distress and enhance parenting skills in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care for Dual Caregivers who Care for Their Partner With Cancer and Their Young Children. Ann-Yi, S., Milbury, K., Jones, M., et al.[2023]

The Parenting Concerns Questionnaire (PCQ) was validated in a study of 209 Portuguese parents with cancer, confirming its effectiveness in identifying parenting concerns and psychological distress related to their condition.

The PCQ demonstrated strong psychometric properties, including reliability and validity, making it a useful tool for identifying parents who may need psychological support, particularly those experiencing depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Parenting Concerns Questionnaire: A validation study with Portuguese parents with cancer. Tavares, R., Brandão, T., Matos, PM.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11214994/

Effectiveness of a comprehensive support program for ... The intervention was associated with a significant reduction in parental distress in the IG (MID 70.4% in at least one parent) compared with the ...

2. academic.oup.com academic.oup.com/oncolo/article/30/7/oyae351/7929275

Supporting patients with advanced cancer and their spouses ... Patients with advanced cancer and their spousal caregivers who parent minor children report unmet parenting concerns and increased psychological ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388924000036

Psychosocial interventions for improving mental health and ... This systematic review aimed to assess the effectiveness of psychosocial interventions targeting parents with cancer on their mental health, quality of life,

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocn.17699?af=R

Effectiveness of Psychosocial Interventions for Parents ... This study showed that psychosocial intervention was beneficial for decreasing anxiety symptoms and depressive symptoms of parents of children with cancer.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39703166/

Supporting patients with advanced cancer and their spouses ... This RCT examined the feasibility, acceptability, and initial evidence for the efficacy of a novel psychosocial intervention.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9983748/

Interventions for children of parents with cancer: an overview The authors report that participants perceived the interventions as helpful, and experienced positive outcomes in terms of quality of life, mental health/mental ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S104084282300207X

Psychosocial interventions targeting parenting distress ... This study aimed to describe available psychosocial interventions for parents with cancer and dependent children (<18 years).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05377749?tab=results

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