Endetarmskræftpatienters seksuelle sundhed
Endetarmskræftpatienters seksuelle sundhed: En pilotundersøgelse
Vi ved, at behandling af rektal-, kolorektal- eller analkræft kan påvirke seksuel funktion. Denne undersøgelse har til formål at lære:
- Hvordan behandlingen påvirker følelsesmæssigt og socialt velvære.
- Hvordan et nyt uddannelsesprogram for seksuel sundhed påvirker dig.
Kræftpatienter søger uddannelse af mange årsager. Det hjælper dem ofte med at klare sig, fordi de kan udtrykke deres følelser med en uddannet professionel. Denne undersøgelse er åben for personer, der er blevet behandlet for rektal-, kolorektal- eller analkræft. Det involverer en ny type seksuelt sundhedsrådgivningsprogram. Det vil lære deltagerne færdigheder, som de kan bruge til at forbedre deres sexliv. Disse færdigheder kan også forbedre fysisk og følelsesmæssigt velvære. Vi vil sammenligne den nye type seksuelt sundhedsprogram med den standardbehandling, patienter får efter behandling for endetarms-, kolorektal- eller analkræft.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Dette er et toårigt randomiseret klinisk forsøg, der undersøger gennemførligheden, tolerabiliteten, acceptabiliteten (inklusive overholdelse) og effektiviteten af en intervention designet til at forbedre seksuel funktion hos overlevende efter endetarmskræft.
Vi har afsluttet indskrivningen af kvindelige patienter og er i øjeblikket ved at indsamle opfølgningsdata. Rekruttering af mandlige patienter er i gang. Mandlige deltagere vil nu blive randomiseret i et 3:1-forhold til enten interventionsbetingelsen (n = 40) eller kontrolbetingelsen (n = 40).
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, Forenede Stater, 10029
- Mount Sinai Hospital
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Mindst seks måneder efter stråling og/eller operation for stadium I-III rektalt adenokarcinom eller rectosigmoid for cancer med en anastomose ved 15 cm eller derunder og afsluttet behandling
- Mindst seks måneder efter stråling og/eller kemoterapi for analkræft.
- Har ingen tegn på sygdom eller tilbagefald
- For kvinder angiver Angiv moderat tilfredshed eller lavere på deres samlede seksuelle liv (en score på "4" eller lavere på spørgsmålet "I løbet af de sidste 4 uger, hvor tilfreds har du været med dit generelle seksuelle liv?"
- For mænd angiver, og en score på "3" eller lavere på spørgsmålet "Hvordan vil du vurdere din tillid til, at du kan få og beholde en erektion" for mænd) og en score på "2" eller højere på spørgsmålet "Hvor meget generer dette problem dig?
- Efter de samtykkende professionelle interventionisters vurdering, i stand til at kommunikere på engelsk godt nok til at arbejde med engelsktalende og gennemføre undersøgelsesvurderingerne.
- Alder 21 år eller ældre.
Ekskluderingskriterier:
- Væsentlig kognitiv eller psykiatrisk forstyrrelse, der efter investigators vurdering er tilstrækkelig til at udelukke deltagelse i en psykoterapeutisk intervention.
- Deltager aktivt i protokol 06-151
- Deltog i fokusgruppe eller kvalitativt interview.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
Intervention / BehandlingIntervention / Behandling |
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1
sædvanlig pleje (UC), som er den standardbehandling, som patienterne modtager
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Deltagere randomiseret til Usual Care-armen vil modtage standardpleje.
For kvinder er dette defineret som den pleje, som deltagere, der ikke er i interventionen, modtager; vi vil spørge disse deltagere, hvilken psykosocial pleje de modtager for at spore sædvanlig pleje.
For mænd vil "sædvanlig pleje" bestå af en standardiseret henvisning til mænds seksuelle medicinprogram på MSKCC og skriftlig information i form af American Cancer Society (ACS) hæfte om seksualitet efter kræft.
Personer, der er randomiseret til Usual Care, vil ikke modtage yderligere rådgivningssessioner fra undersøgelsens interventionister, før de er færdige med de opfølgende samtaler, og derefter vil de blive tilbudt dem.
Opfølgende spørgeskemaer vil vurdere alle studiedeltagere 4 og 8 måneder efter baseline.
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2
Cancer Survivorship Intervention-Sexual Health (CSI-SH) plus usual care (US)
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Dette involverer fire 1-times individuelle sessioner med tre ekstra telefonbooster/review-sessioner mellem de fire sessioner.
Sessioner kan gennemføres personligt eller gennemføres over telefonen.
Selvom der vil blive gjort alt for at fuldføre booster-sessionen mellem rådgivningssessionerne, kan patienten springe over, hvis patienten ikke er tilgængelig for at gennemføre booster-opkaldene.
Session 1 og 2 vil fokusere på rehabiliteringsteknikker og værktøjer vil blive leveret og diskuteret med deltagerne i løbet af disse første to sessioner.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1
Tidsramme: 4 months post-baseline (follow-up 1)
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The FSFI (Female Sexual Functioning Index) is a brief, self-report measure of female sexual function.
The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function.
The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
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4 months post-baseline (follow-up 1)
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Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 2
Tidsramme: 8 months post-baseline (follow up 2)
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The FSFI is a brief, self-report measure of female sexual function.
The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function.
The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
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8 months post-baseline (follow up 2)
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Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
Tidsramme: 4 months post-baseline (follow up 1)
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The IIEF is a 15-item questionnaire designed to assess erectile functioning.
Scores of 0 to 5 are awarded to each of the 15 questions.
The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10).
Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction.
Higher scores indicate better sexual function/better outcome.
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4 months post-baseline (follow up 1)
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Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
Tidsramme: 8 months post-baseline (follow-up 2)
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The IIEF is a 15-item questionnaire designed to assess erectile functioning.
Scores of 0 to 5 are awarded to each of the 15 questions.
The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10).
Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction.
Higher scores indicate better sexual function/better outcome.
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8 months post-baseline (follow-up 2)
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 1
Tidsramme: 4 months post-baseline (follow up 1)
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The IES-R is a self-report measure designed to assess current subjective distress for any specific life event.
Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment.
the total score for the IES-R assessment can range from 0-88.
In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.
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4 months post-baseline (follow up 1)
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Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 2
Tidsramme: 8 months post-baseline (follow up 2)
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The IES-R is a self-report measure designed to assess current subjective distress for any specific life event.
Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment.
the total score for the IES-R assessment can range from 0-88.
In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.
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8 months post-baseline (follow up 2)
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Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 1
Tidsramme: 4 months post-baseline (follow up 1)
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The BSI (Brief Symptom Inventory) consists of 53 items.
Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms.
Higher scores indicate greater emotional distress.
The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days.
Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score.
Higher scores indicate greater emotional distress.
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4 months post-baseline (follow up 1)
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Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 2
Tidsramme: 8 months post-baseline (follow up 2)
|
The BSI (Brief Symptom Inventory) consists of 53 items.
Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms.
Higher scores indicate greater emotional distress.
The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days.
Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score.
Higher scores indicate greater emotional distress.
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8 months post-baseline (follow up 2)
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Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 1
Tidsramme: 4 months post-baseline (follow up 1)
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EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients.
It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL.
Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation.
The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included).
All of the scales and measures range in score from 0 to 100.
A high scale score represents a higher response level/better outcome.
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4 months post-baseline (follow up 1)
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Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 2
Tidsramme: 8 months post-baseline (follow up 2)
|
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients.
It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL.
Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation.
The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included).
All of the scales and measures range in score from 0 to 100.
A high scale score represents a higher response level/better outcome.
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8 months post-baseline (follow up 2)
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Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 1
Tidsramme: 4 months post-baseline (follow up 1)
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The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction.
This measure was developed for use in men with ED.
The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem.
Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable).
The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20).
The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life.
Higher scores indicate better outcomes (better functioning; less bother).
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4 months post-baseline (follow up 1)
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Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 2
Tidsramme: 8 months post-baseline (follow up 2)
|
The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction.
This measure was developed for use in men with ED.
The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem.
Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable).
The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20).
The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life.
Higher scores indicate better outcomes (better functioning; less bother).
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8 months post-baseline (follow up 2)
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Christian Nelson, PhD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Tarmsygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Kolorektale neoplasmer
- Intestinale neoplasmer
- Endetarmssygdomme
- Rektale neoplasmer
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Undersøgelser og spørgeskemaer
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 08-073
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