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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA225615 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Michigan State University | OTHER |
| National Cancer Institute (NCI) | NIH |
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Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms.
High need survivors were randomized initially to the 12-week Symptom Management and Survivorship Handbook (SMSH, N=282) or 12-week SMSH Telephone Interpersonal Counseling (TIPC, N=93) added during weeks 1-8. After 4 weeks of the SMSH alone, non-responders on depression were re-randomized to continue with SMSH alone (N=30) or add TIPC (N=31).
Nearly 15.5 million Americans have survived cancer and virtually all have experienced symptoms from cancer treatment. Numerous symptom management interventions have been tested during active treatment, yet few have addressed the continuing fatigue, pain, depression, etc. that endure following the end of treatment.
Existing post-treatment symptom management research has targeted survivors months after the end of active treatment, overlooking the immediate post-treatment period. During this period, some survivors have their symptoms resolve naturally (low need for intervention), while others suffer from high symptom burden (high need for intervention), with 30% experiencing depression. Sample: Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years.
Design: The SMART design incorporates two interventions with proven efficacy and addresses heterogeneity of survivors' responses by following the clinical logic of starting with one intervention, assessing its success, and continuing it when effective. High need survivors will be initially randomized to receive 1) weekly symptom assessment with referral for elevated symptoms to a printed Symptom Management and Survivorship Handbook (SMSH) or 2) a more intensive intervention adding Telephone Interpersonal Counselling (TIPC) to the SMSH. After 4 weeks, non-responders to SMSH alone on depression were re-randomized to continue SMSH for 8 more weeks to allow for symptom resolution, or TIPC added for the remaining 8 weeks.
The primary outcome was symptom severity index, secondary outcome was depressive symptoms. The hypotheses tests included comparisons of primary and secondary outcomes according tp first randomization and second randomization for non-responders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Need Benchmark or Follow-up | No Intervention | In the low need benchmark or follow-up group, survivors completed detailed baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) at week 4 over the telephone was used to assess symptoms. | |
| High Need A: Start with SMSH alone for 4 weeks | Experimental | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMH to relieve symptoms. After 4 weeks, participants were re-randomized to continue in SMH for 8 more weeks or to add Telephone Interpersonal Counseling (TIPC) Intervention for the subsequent 8 weeks. If the TIPC was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss interpersonal relationships, communication, social support, managing symptoms and survivorship. At week 13, the participant completed the second assessment. |
|
| High Need B: Start with SMSH+TIPC | Experimental | Participants were called every week for the first 8 weeks using a combination of TIP-C and SMH. The counselor called to assess and discuss interpersonal relationships, communication, social support, managing symptoms and survivorship. At the end of 8 weeks, the final 4 calls followed the SMSH alone protocol. At week 13, the second assessment was conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Start with SMSH+TIPC | Behavioral | See arm/group descriptions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Severity Index- Comparison of Two Groups Created by First Randomization | Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated the severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 1-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, with higher score indicating worse outcome (greater severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable. | Weeks 1-13 |
| Symptom Severity Index- Comparison of Two Groups Created by Second Randomization | Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 5-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, higher value reflect worse outcome (greater symptom severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable. | Weeks 5-13 |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms- Comparison of Two Groups Created by First Randomization. | Measured using Center for Epidemiological Studies-Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms). | Week 13 |
| Depressive Symptoms - Comparison of Two Groups Created by Second Randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry Badger, PhD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center at St. Joseph's | Phoenix | Arizona | 85004 | United States | ||
| University of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36801353 | Result | Sikorskii A, Badger T, Segrin C, Crane TE, Chalasani P, Arslan W, Hadeed M, Morrill KE, Given C. A Sequential Multiple Assignment Randomized Trial of Symptom Management After Chemotherapy. J Pain Symptom Manage. 2023 Jun;65(6):541-552.e2. doi: 10.1016/j.jpainsymman.2023.02.005. Epub 2023 Feb 17. |
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We will share the findings and data with other researchers, the public, and key stakeholders based on the principles that NIH has articulated regarding the sharing of study results and resources. The University of Arizona agrees that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve health.
Sharing of study results Manuscript based on results from the proposed study will be published in peer-reviewed journals. We will select "open access" options for these manuscripts whenever possible.
Data Sharing Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. Data and safety monitoring plan is described under Human Subjects.
Anticipate later part of 2022
Data Sharing Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. Data and safety monitoring plan is described under Human Subjects.
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Of 500 consented individuals, 451 had a baseline interview, 71 were low need, 375 were high need and entered into randomization. Five participants were found ineligible. Three participants in the high need group dropped out after baseline before the first randomization. Three participants in the low need group were misclassified initially as high need and were randomized, resulting in 375 randomized and 68 continuing as low need without interventions.
Cancer survivors were recruited at a comprehensive cancer center, a federally qualified health center, and community settings in the Southwestern United States. Participants were informed they would be 1) randomized to SMSH or TIPC+SMSH and may be rerandomized after 4 weeks to continue with SMSH alone or add TIPC; 2) telephone assessment and intervention sessions were weekly for 13 weeks; 3) interventions were designed to help reduce symptoms and there were study incentives.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Need Benchmark or Follow-up | In the low need benchmark or follow-up group, participants received baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) was done at week 4 over the telephone to assess symptoms. Approximately 35% of all participants were in this group. |
| FG001 | High Need- SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression responders in the High Need group continued with the SMSH alone for weeks 5-12. Depression responders were survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the participant was called to complete the second assessment. |
| FG002 | High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment. |
| FG003 | High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment. |
| FG004 | High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for the first 8 weeks using a combination of Telephone Interpersonal Counseling (TIPC) and SMSH. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship as well as asked about symptoms and suggest strategies from the SMSH to relieve symptoms. At weeks 9-12, the participant received the SMSH alone. At week 13, the participant was called to complete the second assessment. |
| FG005 | Drop-outs From SMSH Alone Prior to Week 4 | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. These participants were lost to attrition prior to the week 4 assessment for response or non-response. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Of 500 individuals who consented, 451 completed a baseline and 5 were ineligible.
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Need Benchmark or Follow-up | In the low need benchmark or follow-up group, participants received baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) was done at week 4 over the telephone to assess symptoms. Approximately 35% of all participants were in this group. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Symptom Severity Index- Comparison of Two Groups Created by First Randomization | Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated the severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 1-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, with higher score indicating worse outcome (greater severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable. | Of the 375 high-need survivors initially randomized, 282 received the Symptom Management and Survivorship Handbook (SMSH) alone and 93 received Telephone Interpersonal Counseling (TIPC) + SMSH. | Posted | Least Squares Mean | Standard Error | score on a scale | Weeks 1-13 |
Each participant was assessed for adverse events at baseline (week 0) and weekly for 13 weeks or up until their attrition date if applicable.
Averse events/serious adverse events were identified during the implementation of the experimental protocols and were monitored by the Investigators in several ways: 1) Interviewers could identify both serious adverse events and/or adverse events during the completion of telephone interviews or telephone calls to schedule telephone interviews; 2) The interventionists could identify both serious adverse events and/or adverse events during their telephone contacts with the participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Need Benchmark or Follow-up | In the low need benchmark or follow-up group, participants received baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) was done at week 4 over the telephone to assess symptoms. Approximately 35% of all participants were in this group. |
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The larger than anticipated proportion of high need survivors resulted in a larger sample size for tests of hypotheses associated with first randomization. The higher than anticipated response rate to the SMSH at week 4 resulted in a lower number of survivors in the second randomization compared to the requirements of power analysis. On the other hand, a higher than anticipated rate of response to the SMSH alone led to a larger than planned number of responders.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terry Badger, PhD (MPI) and Alla Sikorskii, PhD (MPI) | University of Arizona College of Nursing | 520-626-6058 | tbadger@arizona.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2021 | Sep 1, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2021 | Jun 9, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Following baseline, symptom management need (high versus low need) will be determined. The low need group will not receive interventions, but will be followed at week 4 for a brief symptom assessment and at week 13. The high need group will be randomly assigned to either: 1) SMSH alone or 2) TIP-C+SMSH for 8 weeks followed by continued 4 weeks of SMSH alone. We will mail the SMSH, printed in the survivor's preferred language, following randomization. All high need participants will receive weekly telephone contacts during weeks 1-12 to assess symptoms, deliver the assigned intervention, and assess intervention enactment and fidelity. After the initial 4 weeks, responders on depression will continue with the SMSH only. Non-responders will re-randomized to either continue with the SMSH alone or add TIP-C. Those initially randomized to TIP-C+SMSH will not be re-randomized. Total duration of each of the three intervention sequences is 12 weeks.
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Data collectors will be blinded to the arm of the study.
| Start with SMSH alone |
| Behavioral |
See arm/group descriptions |
|
Measured using Center for Epidemiological Studies-Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms). |
| Week 13 |
| Tucson |
| Arizona |
| 85721 |
| United States |
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Screen failure |
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| High Need-SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 |
Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression responders in the High Need group continued with the SMSH alone for weeks 5-12. Depression responders are survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the participant was called to complete the second assessment. |
| BG002 | High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment. |
| BG003 | High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment. |
| BG004 | High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for the first 8 weeks using a combination of Telephone Interpersonal Counseling (TIPC) and SMSH. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship as well as asked about symptoms and suggest strategies from the SMSH to relieve symptoms. At weeks 9-12, the participant received the SMSH alone. At week 13, the participant was called to complete the second assessment. |
| BG005 | Drop-outs From SMSH Alone Prior to Week 4 | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. These participants were lost to attrition prior to the week 4 assessment for response or non-response. |
| BG006 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Symptom Severity | Symptoms were measured using the modified General Symptom Distress Scale (GSDS) assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated the severity of each symptom (0= not present,10= worst possible). A summed symptom severity index for 17 symptoms other than depression was derived. The potential range is 0-170, higher score reflects worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Depressive Symptoms | Measured using Center for Epidemiological Studies-Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms). | Mean | Standard Deviation | units on a scale |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | High Need A; Start With SMSH Alone | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, participants were re-randomized to continue in SMSH for 8 more weeks or to add Telephone Interpersonal Counseling (TIP-C) Intervention for the subsequent 8 weeks. If the TIP-C was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss strategies for managing symptoms, provide survivorship education, and discuss interpersonal relationships, communication, and social support. At week 13, the participant was called to complete the second assessment. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions |
| OG001 | High Need B: Start With SMSH+TIPC | Participant was called every week for the first 8 weeks using a combination of TIP-C and SMSH. The counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. At the end of 8 weeks, the final 4 calls were focused on the SMSH protocol. At week 13, the second assessment was conducted. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions |
|
|
|
| Primary | Symptom Severity Index- Comparison of Two Groups Created by Second Randomization | Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 5-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, higher value reflect worse outcome (greater symptom severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable. | Non-responders to the SMSH alone after 4 weeks. | Posted | Least Squares Mean | Standard Error | score on a scale | Weeks 5-13 |
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|
| Secondary | Depressive Symptoms- Comparison of Two Groups Created by First Randomization. | Measured using Center for Epidemiological Studies-Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms). | Of the 375 high-need survivors initially randomized, 282 started with the Symptom Management and Survivorship Handbook (SMSH) alone and 93 received Telephone Interpersonal Counseling (TIPC) + SMSH. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 13 |
|
|
|
|
| Secondary | Depressive Symptoms - Comparison of Two Groups Created by Second Randomization | Measured using Center for Epidemiological Studies-Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms). | Non-responders to the SMSH alone after 4 weeks randomized for the second time (N=61). | Posted | Least Squares Mean | Standard Error | score on a scale | Week 13 |
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|
| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | High Need A-SMH or TIP-C | Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, participants were re-randomized to continue in SMSH for 8 more weeks or to add Telephone Interpersonal Counseling (TIP-C) Intervention for the subsequent 8 weeks. If the TIP-C was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss strategies for managing symptoms, provide survivorship education, and discuss interpersonal relationships, communication, and social support. At week 13, the participant was called to complete the second assessment. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions | 1 | 282 | 0 | 282 | 0 | 282 |
| EG002 | High Need B-TIP-C+SMH | Participant was called every week for the first 8 weeks using a combination of TIP-C and SMSH. The counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. At the end of 8 weeks, the final 4 calls were focused on the SMSH protocol. At week 13, the second assessment was conducted. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions | 3 | 93 | 0 | 93 | 0 | 93 |
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The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4. |
| Superiority |
The key parameter was the coefficient for the variable reflecting trial arm from the second randomization in the mixed model. This parameter reflected average difference between means of two groups over time (weeks 5-13). |
Key parameter was the coefficient for the trial arm from the first randomization variable in the linear regression model. |
| Superiority |
The key parameter was the coefficient for the trial arm from the second randomization variable in linear regression model. |