Mixed Methods Study to Assess Family Members Unmet Needs in an Oncology Setting (SALUTE)

The main questions the study aims to answer are:

1. The proportion of family members of cancer patients who say they need more support
2. What support family members feel would be beneficial

Information about patients' cancer diagnosis and treatment will be collected from their medical notes.

Participating family members will be asked to complete a telephone questionnaire. Selected family members may also be asked to participate in an optional follow-up interview.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Telephone questionnaire

Detailed Description

When someone is diagnosed with cancer, it can be a worrying and stressful time for patients and for their family members. Family members may provide practical and emotional support to patients, and may take on a caregiver role.

Family members may want more information or advice, or may benefit from emotional support themselves. The study aims to identify any gaps in the current support provided to family members so that services can be improved in the future.

Oncology patients in Singleton Hospital, Swansea will be asked by their oncology team to identify one or more family members to participate in the study. If a family member agrees to participate in the study, the research team will call them to complete a telephone questionnaire. The questionnaire should take less than 20 minutes and asks them some general questions (e.g. age, gender) and some questions about how they are feeling, what support services they find helpful and what additional support they feel would be beneficial.

Data regarding participating patients' cancer diagnosis and treatment will be collected from their medical notes.

After the questionnaire data has been analysed, optional follow-up interviews will be conducted with some family members to explore any issues identified in greater detail.

Patients and family members will be recruited during a 6 month recruitment period and all responses will be anonymised.

This is a pilot study which will not change the current support provided to family members, although they may be directed to existing services if appropriate. Patients' treatment will not be changed in any way.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United Kingdom
  • Swansea, United Kingdom
    • South West Wales Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Oncology patients in South West Wales, United Kingdom

Description

Inclusion Criteria for patients

• diagnosed with a solid organ malignancy under the care of the oncology team
• able to identify at least one family member who may be willing to participate in the study

Inclusion Criteria for family members

- a family member of a patient diagnosed with a solid organ malignancy under the care of the oncology team

Exclusion Criteria for patients and family members

• medical or psychiatric condition impairing ability to consent
• the patient's treating oncologist's opinion is that participating in the study would cause severe distress to the patient or their family

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of family members who state they need more support	The proportion of family members who state they need more support	6 months after start of study recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types of additional support that family members feel would be beneficial as identified via the telephone questionnaires and interviews	This will be determined by qualitative analysis of questionnaire and interview data and may include improved psychological support, online resources, information leaflets etc	6 months after start of study recruitment
The proportion of family members who state they need more support with each of the Carer Support Needs Assessment Tool (CSNAT) domains	he proportion of family members who state they need more support with each of the Carer Support Needs Assessment Tool (CSNAT) domains	6 months after start of study recruitment

Collaborators and Investigators

• Sponsor: Swansea Bay University Health Board
• Collaborators: Swansea University
• Investigators: Principal Investigator: Sing Yu Moorcraft, Swansea Bay University Health Board

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 331660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No