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

207 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well information materials work in helping communication between physicians and participants with cancer that has spread to other places in the body and their caregivers. Approaches that encourage participants to actively participate and ask appropriate questions during their visit may be important to enhance their understanding of their illness and empower them to make important decisions regarding their medical care.

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 data supports the effectiveness of the treatment Informational Intervention, Educational Program, Parenting Intervention, Informational Support for cancer communication?

Research shows that providing information to cancer patients and their families can reduce uncertainty and improve their sense of control, which is crucial in managing the stress of cancer treatment. Studies highlight the importance of tailored information to meet the specific needs of patients and parents, suggesting that informational support is a key component of effective cancer care. ^{1 2 3 4 5}

Is the Informational Intervention for Cancer Communication safe for humans?

The research highlights the importance of educational programs in cancer care, showing that a lack of information can lead to adverse events. However, there is no specific safety data for the Informational Intervention itself, but educational interventions generally aim to improve patient safety by providing necessary information. ^{6 7 8 9 10}

How does the Informational Intervention treatment for cancer communication differ from other treatments?

The Informational Intervention treatment is unique because it focuses on providing educational support and improving communication between cancer patients and their families, rather than directly targeting the cancer itself. This approach helps patients and their loved ones better understand the disease and treatment options, which can improve coping strategies and overall satisfaction with care. ^{2 7 11 12 13}

Research Team

Joseph A Arthur

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Information needs of Malaysian parents of children with cancer: A qualitative study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Information disclosure to cancer patients: EORTC QLQ-INFO25 questionnaire. [2022]

3. Scotland pubmed.ncbi.nlm.nih.gov

A moment just for me - parents' experiences of an intervention for person-centred information in paediatric oncology. [2021]

4. Scotland pubmed.ncbi.nlm.nih.gov

Survey on learning needs and preferred sources of information to meet these needs in Italian oncology patients receiving chemotherapy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The role of information in patients' adaptation to chemotherapy and radiotherapy: a review of the literature. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Coping with cancer: the impact of the Cancer Information Service on patients and significant others. Part 6. [2007]

8. Ireland pubmed.ncbi.nlm.nih.gov

Untangling interactivity's effects: The role of cognitive absorption, perceived visual informativeness, and cancer information overload. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Commonly Reported Adverse Events Associated With Pediatric Immunotherapy: A Systematic Review From the Children's Oncology Group [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Effective Information Provision About the Side Effects of Treatment for Malignant Lymphoma: Protocol of a Randomized Controlled Trial Using Video Vignettes. [2020]

12. Ireland pubmed.ncbi.nlm.nih.gov

Information to and communication with cancer patients: improvements and psychosocial correlates in a comprehensive care program for patients and their relatives. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Cancer patient and survivor research from the cancer information service research consortium: a preview of three large randomized trials and initial lessons learned. [2021]