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

Sponsor
Swansea Bay University Health Board (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06142071
Collaborator
Swansea University (Other)
50
8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Mixed Methods Study to Assess Family Members Unmet Needs in an Oncology Setting
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Outcome Measures

Primary Outcome Measures

  1. The proportion of family members who state they need more support [6 months after start of study recruitment]

Secondary Outcome Measures

  1. The 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]

  2. Types of additional support that family members feel would be beneficial as identified via the telephone questionnaires and interviews [6 months after start of study recruitment]

    This will be determined by qualitative analysis of questionnaire and interview data and may include improved psychological support, online resources, information leaflets etc

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Swansea Bay University Health Board
  • Swansea University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Swansea Bay University Health Board
ClinicalTrials.gov Identifier:
NCT06142071
Other Study ID Numbers:
  • 331660
First Posted:
Nov 21, 2023
Last Update Posted:
Nov 21, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 21, 2023