CancerSALUTENCT06142071
Mixed Methods Study to Assess Family Members Unmet Needs in an Oncology Setting
An observational study of Cancer, run by Swansea Bay University Health Board at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Telephone questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2024to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncology patients in South West Wales, United Kingdom
Who may be able to join
- 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
- a family member of a patient diagnosed with a solid organ malignancy under the care of the oncology team
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The main questions the study aims to answer are:
- The proportion of family members of cancer patients who say they need more support
- 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Telephone questionnaire
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone questionnaireBehavioural
Telephone questionnaire, which includes questions on participant's demographics, anxiety/depression scores, what support they find helpful and what additional support they feel would be beneficial
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of family members who state they need more support
The proportion of family members who state they need more support
Measured: 6 months after start of study recruitment
Secondary outcomes (2)
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
Measured: 6 months after start of study recruitment
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
Measured: 6 months after start of study recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start8 Jan 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea Bay University Health Board
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University
- Responsible party
- Sponsor
- Investigators
- Sing Yu Moorcraft, Principal investigator, Swansea Bay University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142071
- Sponsor's protocol ID
- 331660
- Acronym
- SALUTE
- Status last verified
- Jul 2024
- First submitted
- 26 Oct 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Methods Study to Assess Family Members Unmet Needs in an Oncology Setting
- ClinicalTrials.gov ID
- NCT06142071
- Acronym / sponsor ID
- SALUTE / 331660
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Swansea Bay University Health BoardUniversity, hospital or other
- Collaborators
- Swansea University
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main questions the study aims to answer are:
- The proportion of family members of cancer patients who say they need more support
- 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.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology patients in South West Wales, United Kingdom
Key inclusion criteria (3 listed)
- 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
- a family member of a patient diagnosed with a solid organ malignancy under the care of the oncology team
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone questionnaireTelephone questionnaire, which includes questions on participant's demographics, anxiety/depression scores, what support they find helpful and what additional support they feel would be beneficial | Behavioural | – |
Primary outcome
The proportion of family members who state they need more support
Time frame: 6 months after start of study recruitment
The proportion of family members who state they need more support
2 secondary outcomes
The proportion of family members who state they need more support with each of the Carer Support Needs Assessment Tool (CSNAT) domains
Time frame: 6 months after start of study recruitment
Types of additional support that family members feel would be beneficial as identified via the telephone questionnaires and interviews
Time frame: 6 months after start of study recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sing Yu Moorcraft principal investigator
Swansea Bay University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Swansea Bay University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of family members who state they need more support (time frame: 6 months after start of study recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.