Breast CancerNCT00984321
A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer
A study testing group intervention and questionnaires, individual phone intervention and questionnaires and expressive writing (arm will not be include in the randomization) in people with Breast Cancer and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to examine whether psychoeducation counseling for older cancer patients undergoing treatment is feasible and worthwhile. The investigators will test this in a group or individual phone counseling format. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Lung Cancer
- What is being tested?
- group intervention and questionnaires, individual phone intervention and questionnaires and expressive writing (arm will not be include in the randomization)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2009to 12 Feb 2025
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Have a diagnosis of prostate, breast cancer lung, lymphoma, or gynecological.
- Are receiving active treatment (e.g., radiation, hormone, or chemotherapy)or have been receiving treatment in the past 6 months for prostate, breast, lung, lymphoma, or gynecological cancer
- Are 70 years old or older
- Greater than 6-months post diagnosis
- Have a Distress Thermometer score of 4 or greater or
- a score of ≥ 6 on the Depression or Anxiety subscale of the HADS
Show all 9Show fewer
- Have a Karnofsky Performance Rating of 60 or greater
- In the investigator's judgment, participants must have satisfactory cognitive function to provide valid informed consent and participate in Geriatric Specific Psychoeducational Intervention. The Blessed Orientation-Memory-Concentration test (BOMC) will be used as a cognitive screening tool. Patients must have a BOMC score of less than or equal to 11.
- Able to converse, write and read in English. The questionnaires were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require a very lengthy process of reestablishing the reliability and validity and the establishment of norms for these measures. Therefore, participants must be able to communicate in English to complete the questionnaires.
Who cannot join
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention (e.g., acute psychiatric symptoms which requires individual treatment).
- As per self-report or review of the patient's medical record, if the patient is taking anti-depressant medication, fewer than three months on the same dose of anti-depressant medication.
- Actively participating in protocol 07-094 or 11-021
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Joan Karnell Cancer Center at Pennsylvania
Philadelphia, Pennsylvania, 19106
About this study
The purpose of this study is to examine whether psychoeducation counseling for older cancer patients undergoing treatment is feasible and worthwhile. The investigators will test this in a group or individual phone counseling format. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. This geriatric-specific psychoeducation is intended to help older cancer patients cope with the burden of cancer and aging. The purpose of this study is to see if this type of counseling helps reduce depressive symptoms, anxiety, perception of loneliness and isolation. In addition this counseling aims to improve coping and quality of life (QOL).
Individuals who choose not to take part in the intervention study will be asked if they are willing to participate in a brief refusal sub study. The purpose of the refusal substudy is to compare levels of distress in patients that choose to participate and those that decline. This will yield valuable data that will help us distinguish between patients that decline due to lack of interest in research and those that decline due to high levels of distress. Participation in the refusal sub study consists of completion of 2 brief questionnaires.
- Being tested
- group intervention and questionnaires, individual phone intervention and questionnaires, expressive writing (arm will not be include in the randomization)
- Keywords
- Geriatric, Elderly, Counseling, Depression, Anxiety, Intervention, Psychoeducational, 09-116
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group intervention and questionnairesBehavioural
Group Session will be 90 minutes long. Both the group sessions and individual session will be audio recorded. GSPI is a novel, manualized psychoeducational intervention that integrates Folkman's cognitive construct and Erikson's developmental concept of the 7th and 8th stages of life. GSPI consist of 5 weekly sessions. The first 2 sessions will be held on consecutive weeks to help establish rapport and explain therapeutic concepts, and next 3 sessions will be held every other week, giving patients time to utilize the therapeutic concepts and expanding length of contact with the patient.
individual phone intervention and questionnairesBehavioural
Individual phone sessions will be 45 minutes long. Both the group sessions and individual session will be audio recorded. GSPI is a novel, manualized psychoeducational intervention that integrates Folkman's cognitive construct and Erikson's developmental concept of the 7th and 8th stages of life. GSPI consist of 5 weekly sessions. The first 2 sessions will be held on consecutive weeks to help establish rapport and explain therapeutic concepts, and next 3 sessions will be held every other week, giving patients time to utilize the therapeutic concepts and expanding length of contact with the patient.
expressive writing (arm will not be include in the randomization)Behavioural
intervention facilitate "reappraisal" through the exploration of past life events and prior successful ways of coping. Preliminary studies examining the efficacy of this writing intervention have shown its' ability to introduce patients to a new and effective coping method that can be utilized during future stressful cancer and aging related events.67 In the sessions, Wwe will explore past life events and ways of coping through manualized writing sessions.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational Intervention Group | Experimental | Not described Receives: Behavioral: individual phone intervention and questionnaires |
| Expressive Writing Intervention | Experimental | Not described Receives: Behavioral: expressive writing (arm will not be include in the randomization) |
| Control Group | Active comparator | Not described Receives: Behavioral: group intervention and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the feasibility, tolerability and acceptability of a Geriatric Specific Psychoeducational Intervention (GSPI) by examining the rates of eligibility, acceptance, and adherence.
Measured: 2 years
Secondary outcomes (1)
To examine the impact of these GSPI in both formats on depressive symptoms, anxiety, demoralization, coping, loneliness and isolation, and spirituality compared to the control group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study start22 Sep 2009
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Joan Karnell Cancer Center at Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Christian Nelson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984321
- Sponsor's protocol ID
- 09-116
- Status last verified
- Feb 2025
- First submitted
- 23 Sep 2009
- Last updated
- 13 Feb 2025
- Results posted
- No
Publications
Tutino RC, Saracino RM, Kelman J, Schofield EA, Roth AJ, Nelson CJ. Cancer and aging: Reflections for elders- Expressive writing intervention: A pilot study. J Geriatr Oncol. 2022 Jun;13(5):706-714. doi: 10.1016/j.jgo.2022.02.009. Epub 2022 Mar 2.
PubMed 35246404
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer
- ClinicalTrials.gov ID
- NCT00984321
- Acronym / sponsor ID
- 09-116
- Keywords
- Geriatric, Elderly, Counseling, Depression, Anxiety, Intervention, Psychoeducational, 09-116
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Joan Karnell Cancer Center at Pennsylvania
- Study start
- 22 Sep 2009 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 25 Sep 2009 (estimated)
- 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 purpose of this study is to examine whether psychoeducation counseling for older cancer patients undergoing treatment is feasible and worthwhile. The investigators will test this in a group or individual phone counseling format. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. This geriatric-specific psychoeducation is intended to help older cancer patients cope with the burden of cancer and aging. The purpose of this study is to see if this type of counseling helps reduce depressive symptoms, anxiety, perception of loneliness and isolation. In addition this counseling aims to improve coping and quality of life (QOL).
Individuals who choose not to take part in the intervention study will be asked if they are willing to participate in a brief refusal sub study. The purpose of the refusal substudy is to compare levels of distress in patients that choose to participate and those that decline. This will yield valuable data that will help us distinguish between patients that decline due to lack of interest in research and those that decline due to high levels of distress. Participation in the refusal sub study consists of completion of 2 brief questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational Intervention Group | Experimental | Behavioral: individual phone intervention and questionnaires |
| Expressive Writing Intervention | Experimental | Behavioral: expressive writing (arm will not be include in the randomization) |
| Control Group | Active comparator | Behavioral: group intervention and questionnaires |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Have a diagnosis of prostate, breast cancer lung, lymphoma, or gynecological.
- Are receiving active treatment (e.g., radiation, hormone, or chemotherapy)or have been receiving treatment in the past 6 months for prostate, breast, lung, lymphoma, or gynecological cancer
- Are 70 years old or older
- Greater than 6-months post diagnosis
- Have a Distress Thermometer score of 4 or greater or
Key exclusion criteria (3 listed)
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention (e.g., acute psychiatric symptoms which requires individual treatment).
- As per self-report or review of the patient's medical record, if the patient is taking anti-depressant medication, fewer than three months on the same dose of anti-depressant medication.
- Actively participating in protocol 07-094 or 11-021
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 |
|---|---|---|
| group intervention and questionnairesGroup Session will be 90 minutes long. Both the group sessions and individual session will be audio recorded. GSPI is a novel, manualized psychoeducational intervention that integrates Folkman's cognitive construct and Erikson's developmental concept of the 7th and 8th stages of life. GSPI consist of 5 weekly sessions. The first 2 sessions will be held on consecutive weeks to help establish rapport and explain therapeutic concepts, and next 3 sessions will be held every other week, giving patients time to utilize the therapeutic concepts and expanding length of contact with the patient. | Behavioural | Control Group |
| individual phone intervention and questionnairesIndividual phone sessions will be 45 minutes long. Both the group sessions and individual session will be audio recorded. GSPI is a novel, manualized psychoeducational intervention that integrates Folkman's cognitive construct and Erikson's developmental concept of the 7th and 8th stages of life. GSPI consist of 5 weekly sessions. The first 2 sessions will be held on consecutive weeks to help establish rapport and explain therapeutic concepts, and next 3 sessions will be held every other week, giving patients time to utilize the therapeutic concepts and expanding length of contact with the patient. | Behavioural | Psychoeducational Intervention Group |
| expressive writing (arm will not be include in the randomization)intervention facilitate "reappraisal" through the exploration of past life events and prior successful ways of coping. Preliminary studies examining the efficacy of this writing intervention have shown its' ability to introduce patients to a new and effective coping method that can be utilized during future stressful cancer and aging related events.67 In the sessions, Wwe will explore past life events and ways of coping through manualized writing sessions. | Behavioural | Expressive Writing Intervention |
Primary outcome
To test the feasibility, tolerability and acceptability of a Geriatric Specific Psychoeducational Intervention (GSPI) by examining the rates of eligibility, acceptance, and adherence.
Time frame: 2 years
1 secondary outcome
To examine the impact of these GSPI in both formats on depressive symptoms, anxiety, demoralization, coping, loneliness and isolation, and spirituality compared to the control group.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 35246404Tutino RC, Saracino RM, Kelman J, Schofield EA, Roth AJ, Nelson CJ. Cancer and aging: Reflections for elders- Expressive writing intervention: A pilot study. J Geriatr Oncol. 2022 Jun;13(5):706-714. doi: 10.1016/j.jgo.2022.02.009. Epub 2022 Mar 2.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Christian Nelson, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group intervention and questionnaires, individual phone intervention and questionnaires and expressive writing (arm will not be include in the randomization) in people with Breast Cancer and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
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 9 inclusion and 3 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: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To test the feasibility, tolerability and acceptability of a Geriatric Specific Psychoeducational Intervention (GSPI) by examining the rates of eligibility, acceptance, and adherence. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00984321, which also lists 1 linked publication.
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 13 Feb 2025.