Informational Intervention for Cancer Communication

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Refusal to participate

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with advanced cancer and their caregivers improve communication with doctors. Participants will use special information materials designed to encourage questions and enhance understanding of their condition. The trial tests two different methods, QPS and GIS, to determine which is more effective. It is intended for those diagnosed with advanced cancer, attending a palliative care consultation, and able to read and communicate in English. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance doctor-patient communication for future patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this informational intervention is safe?

Research has shown that informational activities, like those in this trial, are generally safe. These activities provide participants with information to help them communicate more effectively with their doctors.

Previous studies have found that these activities do not involve any physical treatments or medications. Instead, they aim to improve understanding and communication. As a result, there are no known physical side effects or risks for participants.

The trial is labeled as "Not Applicable" for a phase, indicating a focus on support and education rather than testing a new drug or medical procedure. This suggests that the activity is well-tolerated and poses minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to improve communication between cancer patients and their healthcare providers. Unlike traditional methods that rely heavily on routine consultations, this trial uses innovative informational interventions like QPS and GIS to enhance understanding and engagement. These interventions aim to empower patients with better information, potentially leading to more informed decisions and improved overall care experiences. By focusing on communication, this trial could pave the way for more personalized and effective cancer care strategies.

What evidence suggests that this informational intervention is effective for cancer communication?

This trial will compare two informational interventions to help cancer patients communicate more effectively with their healthcare team. Research has shown that providing information aids cancer patients in talking more easily with their doctors. Studies have found that support programs enhance understanding of illness and assist in making important care decisions. For example, one study found that educational counseling improved communication and quality of life for cancer patients and their families. Another study showed that emotional support reduced anxiety and depression in parents of children with cancer. These findings suggest that providing information can help patients with advanced cancer communicate more effectively with their healthcare team. ^{2 4 5 6 7}

Who Is on the Research Team?

Joseph A Arthur

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking cancer patients with advanced disease visiting a palliative care specialist for the first time, along with their caregivers who are involved in their care. Participants must be able to understand and communicate effectively without cognitive impairments. Physicians seeing these patients on the study day can also join.

Inclusion Criteria

I have seen a palliative care specialist for the first time as an outpatient.

A palliative medicine specialist

Is willing to participate in the study and able to complete the questionnaires

Exclusion Criteria

I do not want to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a question prompt sheet (QPS) or a general information sheet (GIS) and answer questions from the physician

6 weeks

1 visit (in-person)

Follow-up

Participants receive both QPS and GIS at the follow-up visit and are monitored for changes in anxiety state and satisfaction

Up to 3 years

Multiple visits (in-person)

Open-label extension

Participants' overall preference between the QPS and GIS is assessed in an open-label phase

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Informational Intervention

Trial Overview The study compares two ways of sharing information: 'Question Prompt Sheet' (QPS), designed to encourage active patient participation and questions, versus standard general information sheets given during consultations between physicians, patients, and caregivers.

How Is the Trial Designed?

Group I: Group I (QPS) Experimental Treatment 2 Interventions

Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.

Group II: Group II (GIS) Active Control 2 Interventions

Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.

Informational Intervention is already approved in United States for the following indications:

Approved in United States as Informational Intervention for:

• Support for parents with advanced cancer and their children

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 qualitative study involving 14 parents of children with cancer and 8 healthcare providers in Malaysia identified three key themes of information needs: interaction with the healthcare system, care for the child at home, and psychosocial support for parents.

Addressing these information needs is crucial for enhancing psychosocial care, as it empowers parents in their caregiving roles and highlights the necessity for tailored informational resources from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information needs of Malaysian parents of children with cancer: A qualitative study. Tan, CE., Lau, SCD., Latiff, ZA., et al.[2022]

Immunotherapy is becoming an effective treatment for pediatric cancers, offering a different mechanism of action compared to traditional chemotherapy, which leads to unique adverse events (AEs).

A systematic review of 17 articles identified common AEs associated with five key immunotherapy agents, emphasizing the need for nurses to understand these specific AEs to effectively monitor and manage pediatric patients undergoing immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commonly Reported Adverse Events Associated With Pediatric Immunotherapy: A Systematic Review From the Children's Oncology Group Withycombe, JS., Carlson, A., Coleman, C., et al.[2022]

The Cancer Information Service (CIS) effectively supports individuals coping with cancer, with 92% of callers satisfied with the information provided and 95% finding the specialists knowledgeable and trustworthy.

Significant others of cancer patients reported greater satisfaction with the information received compared to the patients themselves, highlighting the need for tailored communication strategies to meet the distinct needs of both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping with cancer: the impact of the Cancer Information Service on patients and significant others. Part 6. Darrow, SL., Speyer, J., Marcus, AC., et al.[2007]

In a study of 101 adult cancer patients undergoing chemotherapy, 83% reported experiencing adverse events, highlighting the common side effects of anticancer drugs.

The research found that 11% of adverse events and a significant portion of medical consultations and hospitalizations were linked to a lack of therapeutic education, emphasizing the need for better patient education on treatment and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. Santucci, R., Aatmani, AE., Lescoute, A., et al.[2017]

The My Child's Safety web-based education program significantly improved caregivers' awareness of patient safety for children with cancer, as shown by pre- and post-test results.

After using the program, caregivers felt more empowered to ask questions about procedures and treatments, indicating an increase in their understanding of their rights during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of My Child's Safety Web-Based Program for Caregivers of Children with Cancer in South Korea. Park, BK., Lee, E.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36344827/

Efficacy of a support intervention designed to improve ... This randomized pilot study was conducted to test the feasibility, acceptability, and efficacy of a 4-session intervention designed to improve parents' ...

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

Effectiveness of a comprehensive support program for ... Effectiveness of a comprehensive support program for families with parental cancer (Family-SCOUT): results of a multicenter non-randomized controlled trial

3. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125000333

Providing care to cancer patients parenting minor children Results showed that HCPs' communication about child- and family-related aspects for cancer patients parenting minor children varies widely.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT01723943

Educational Counseling in Improving Communication and ... This randomized clinical trial studies educational counseling in improving communication and quality of life in spouses and breast cancer patients.

6. withpower.com withpower.com/trial/phase-neoplasms-8-2017-4a2ec

Informational Intervention for Cancer Communication This trial studies how well information materials work in helping communication between physicians and participants with cancer that has spread to other ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05377749

The Families Addressing Cancer Together Intervention for ... The proposed pilot randomized controlled trial will test the FACT (Families Addressing Cancer Together) intervention designed to improve parents' confidence ...